January | February | March | April | May | June | July | August | September | October | November | December |
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Drug | Description | FDA approved use | Company | FDA filing | Pathway | Date |
Cabometyx (cabozantinib) | Multityrosine kinase inhibitor | Advanced renal cell carcinoma | Exelixis Inc., of Alameda, Calif. | sNDA | N/A | 1/22/21 |
Carbaglu tablets 200 mg | Carglumic acid | Acute hyperammonemia due to propionic acidemia or methylmalonic acidemia | Recordati SpA, of Milan, Italy | sNDA | N/A | 1/26/21 |
Darzalex Faspro (daratumumab and hyaluronidase-fihj) | ADP ribosyl cyclase-1 inhibitor | Newly diagnosed light-chain amyloidosis | Genmab A/S, of Copenhagen, Denmark, Johnson & Johnson, of New Brunswick, N.J., and Halozyme Inc., of San Diego | sBLA | N/A | 1/15/21 |
Enhertu (trastuzumab deruxtecan) | Antibody-drug conjugate targeting HER2 | HER2-positive gastric or gastroesophageal junction adenocarcinoma | Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo | sBLA | Priority | 1/18/21 |
Lupkynis (voclosporin) | Calcineurin inhibitor | Lupus nephritis | Aurinia Pharmaceuticals Inc., of Victoria, British Columbia | NDA | NME; priority | 1/22/21 |
Nubeqa (darolutamide) | Androgen receptor inhibitor | Non-metastatic castration-resistant prostate cancer | Bayer AG, of Leverkusen, Germany | sNDA | N/A | 1/8/21 |
Verquvo (vericiguat) | Soluble guanylate cyclase stimulator | Heart failure | Merck & Co. Inc., of Kenilworth, N.J. | NDA | NME; priority | 1/19/21 |
Vocabria and Cabenuva | Cabotegravir tablet formulation as lead-in to cabotegravir and rilpivirine extended-release injectable suspensions | HIV-1 infection | Viiv Healthcare Ltd., of London | NDA | NME; priority | 1/21/21 |
Xalkori (crizotinib) | Tyrosine kinase inhibitor | Anaplastic large-cell lymphoma | Pfizer Inc., of New York | sNDA | N/A | 1/14/21 |
Amondys 45 (casimersen) | Phosphorodiamidate morpholino oligomer | Duchenne muscular dystrophy | Sarepta Therapeutics Inc., of Cambridge, Mass. | NDA | Priority; accelerated; orphan; NME | 2/25/21 |
Botox (onabotulinumtoxinA) | Acetylcholine receptor antagonist; p130Cas associated protein inhibitor | Bladder muscle overactivity associated with neurologic condition | Abbvie Inc., of North Chicago | sBLA | N/A | 2/10/21 |
Breyanzi (lisocabtagene maraleucel) | Anti-CD19 CAR T therapy | Relapsed or refractory large B-cell lymphoma | Bristol Myers Squibb Co., of New York | BLA | Priority | 2/5/21 |
Cosela (trilaciclib) | Myelopreservation agent | To reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for small cell lung cancer | G1 Therapeutics Inc., of Research Triangle Park, N.C. | NDA | Standard; NME; priority | 2/12/21 |
Evkeeza (evinacumab) | Monoclonal antibody targeting angiopoietin-like 3 | Homozygous familial hypercholesterolemia | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | BLA | Priority; NME | 2/11/21 |
Gocovri (amantadine) | Reduces the amount of glutamate hyperactivity | Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing off episodes | Adamas Pharmaceuticals Inc., of Emeryville, Calif. | sNDA | N/A | 2/1/21 |
Humira (adalimumab) | Monoclonal antibody targeting tumor necrosis factor | Moderately to severely active ulcerative colitis | Abbvie Inc., of North Chicago | sBLA | N/A | 2/24/21 |
Libtayo (cemiplimab) | Monoclonal antibody targeting PD-1 | Advanced non-small cell lung cancer | Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | Priority | 2/22/21 |
Libtayo (cemiplimab-rwlc) | Anti-PD-1 antibody | Basal cell carcinoma | Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | N/A | 2/9/21 |
Nulibry (fosdenopterin) | Substrate replacement therapy | Molybdenum cofactor deficiency type A | Bridgebio Pharma Inc., of Palo Alto, Calif., and affiliate Origin Biosciences Inc. | NDA | Priority; NME | 2/26/21 |
Panzyga (immune globulin intravenous, human) | Liquid preparation of immune globulin | Chronic inflammatory demyelinating polyneuropathy | Pfizer Inc., of New York | sBLA | N/A | 2/16/21 |
Pepaxto (melphalan flufenamide) | Peptide-drug conjugate | Relapsed or refractory multiple myeloma | Oncopeptides AB, of Waltham, Mass. | NDA | Priority; NME | 2/26/21 |
Posimir (bupivacaine extended-release solution) | Binds to intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells | Postoperative pain | Durect Corp., of Cupertino, Calif. | NDA | Priority | 2/2/21 |
Plegridy (peginterferon beta-1a) | Interferon-beta ligand | Relapsing forms of multiple sclerosis | Biogen Inc., of Cambridge, Mass. | sBLA | N/A | 2/1/21 |
Rapivab (peramivir) | Cyclopentane analogue | Acute uncomplicated influenza | Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. | sNDA | N/A | 2/3/21 |
Tepmetko (tepotinib) | MET inhibitor | Metastatic non-small-cell lung cancer | EMD Serono, part of Darmstadt, Germany-based Merck KGaA | NDA | Priority; NME; orphan | 2/3/21 |
Ukoniq (umbralisib) | Oral PI3K delta and CK1 epsilon inhibitor | Marginal zone lymphoma and follicular lymphoma | TG Therapeutics Inc., of New York | NDA | Priority; NME; accelerated | 2/5/21 |
Abecma (idecabtagene vicleucel) | CAR T targeting B-cell maturation antigen | Relapsed or refractory multiple myeloma | Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. | BLA | Priority | 3/26/21 |
Actemra/Roactemra (tocilizumab) | IL-6 inhibitor | To slow the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease | Roche Holding AG, of Basel, Switzerland | sBLA | N/A | 3/5/21 |
Azstarys (serdexmethylphenidate and dexmethylphenidate, formerly KP-415) | Alpha 2 adrenoceptor agonist | Attention deficit hyperactivity disorder | Kempharm Inc., of Celebration, Fla. | NDA | NME; priority | 3/2/21 |
Dupixent (dupilumab) | Monoclonal antibody targeting the interleukin-4 and interleukin-13 pathways | Moderate to severe asthma | Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | N/A | 3/4/21 |
Flucelvax Quadrivalent | Cell-based quadrivalent vaccine | Influenza | Seqirus Inc., of Summit, N.J. | sBLA | N/A | 3/5/21 |
Fotivda (tivozanib) | VEGF tyrosine kinase inhibitor | Renal cell carcinoma | Aveo Oncology (formerly Aveo Pharmaceuticals Inc.), of Boston | NDA | NME; standard | 3/10/21 |
Keytruda (pembrolizumab) | Monoclonal antibody targeting PD-1 | Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 3/22/21 |
Kimyrsa (oritavancin) | Lipoglycopeptide antibiotic | Acute bacterial skin and skin structure infections | Melinta Therapeutics, of Morristown, N.J. | sNDA | N/A | 3/15/21 |
Lomecel-B | Allogeneic, bone marrow-derived medicinal signaling cell product | Hypoplastic left heart syndrome | Longeveron Inc., of Miami | BLA | N/A | 3/11/21 |
Lorbrena (lorlatinib) | Anaplastic lymphoma kinase inhibitor | First-line anaplastic lymphoma kinase-positive non-small cell lung cancer | Pfizer Inc., of New York | sNDA | Accelerated; priority | 3/4/21 |
Myrbetriq and Myrbetriq Granules (mirabegron) | Beta 3 adrenoceptor agonist | Neurogenic detrusor overactivity | Astellas Pharma Inc., of Tokyo | sNDA | Priority | 3/25/21 |
Ponvory (ponesimod) | Sphingosine-1-phosphate receptor 1 modulator | Relapsing forms of multiple sclerosis | Johnson & Johnson, of New Brunswick, N.J., and Idorsia Ltd., of Allschwil, Switzerland | NDA | NME; priority | 3/19/21 |
Rilonacept | Recombinant dimeric fusion protein blocking interleukin-2-alpha and interleukin-1-beta signaling | Recurrent pericarditis | Kiniksa Pharmaceuticals Ltd., of Hamilton, Bermuda | sBLA | Priority | 3/18/21 |
Sarclisa (isatuximab-irfc) | Monoclonal antibody targeting an epitope on the CD38 receptor on multiple myeloma cells | Relapsed or refractory multiple myeloma | Sanofi SA, of Paris | sBLA | N/A | 3/31/21 |
Tepezza (teprotumumab) | Insulin-like growth factor 1 receptor antagonist | Thyroid eye disease | Horizon Therapeutics plc, of Dublin | sBLA | N/A | 3/30/21 |
Vazalore 325 mg and Vazalore 81 mg | Liquid-filled aspirin capsule | Platelet inhibition | Plx Pharma Inc., of Sparta, N.J. | sNDA | N/A | 3/1/21 |
Vyxeos (daunorubicin and cytarabine) | DNA/RNA polymerase inhibitor, liposomal formulation | Acute myeloid leukemia | Jazz Pharmaceuticals plc, of Dublin | sNDA | N/A | 3/30/21 |
Yescarta (axicabtagene ciloleucel) | CAR T therapy | Relapsed or refractory follicular lymphoma | Gilead Sciences Inc., of Foster City, Calif., and its Kite company | sBLA | Accelerated | 3/5/21 |
Zegalogue (dasiglucagon) injection | Glucagon analogue | Severe hypoglycemia in people with diabetes | Zealand Pharma A/S, of Copenhagen | NDA | NME; priority | 3/22/21 |
Dostarlimab (Jemperli) | Anti-PD-1 antagonist antibody | Endometrial cancer | Anaptysbio Inc., of San Diego, and Glaxosmithkline plc, of London | NDA | Accelerated; NME; priority | 4/22/21 |
Farxiga (dapagliflozin) | SGLT2 inhibitor | Chronic kidney disease | Astrazeneca plc, of Cambridge, U.K. | sNDA | N/A | 4/30/21 |
Kloxxado nasal spray 8 mg | Naloxone hydrochloride | Known or suspected opioid overdose | Hikma Pharmaceuticals plc, of London | NDA | Standard | 4/30/21 |
Nextstellis (drospirenone + estetrol) | Estrogen receptor modulator | Contraception | Mayne Pharma Group Ltd., of Adelaide, Australia, and Mithra Pharmaceuticals SA, of Liege, Belgium | NDA | NME; standard | 4/15/21 |
Opdivo (nivolumab) | Monoclonal antibody targeting PD-1 | Advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression | Bristol Myers Squibb Co., of New York | sBLA | Priority | 4/16/21 |
Praluent (alirocumab) | Anti-PCSK9 antibody | Homozygous familial hypercholesterolemia | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | N/A | 4/1/21 |
Qelbree (viloxazine extended-release capsules) | Norepinephrine reuptake inhibitor | Attention-deficit hyperactivity disorder | Supernus Pharmaceuticals Inc., of Rockville, Md. | NDA | NME; standard | 4/2/21 |
Ragwitek (short ragweed pollen allergen extract) | Sublingual allergy immunotherapy | Short ragweed pollen-induced allergic rhinitis | Alk Inc., of Round Rock, Texas | sBLA | N/A | 4/19/21 |
Trodelvy (sacituzumab govitecan-hziy) | Trop-2-directed antibody/topoisomerase inhibitor conjugate | Urothelial cancer | Gilead Sciences Inc., of Foster City, Calif. | sBLA | Accelerated | 4/13/21 |
Trodelvy (sacituzumab govitecan-hziy) | Trop-2-directed antibody/topoisomerase inhibitor conjugate | Breast cancer | Gilead Sciences Inc., of Foster City, Calif. | sBLA | N/A | 4/7/21 |
Tyvaso (treprostinil) | Dilates blood vessels | Pulmonary hypertension associated with interstitial lung disease | United Therapeutics Corp., of Silver Spring, Md. | sNDA | N/A | 4/1/21 |
Xolair (omalizumab) | Antibody designed to target and block immunoglobulin E | Moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps | Novartis AG, of Basel, Switzerland | sBLA | N/A | 4/13/21 |
Ztlido (lidocaine) | Anesthetic | Pain associated with postherpetic neuralgia | Scilex Holding, a unit of Sorrento Therapeutics Inc., of Palo Alto, Calif. | sNDA | N/A | 4/9/21 |
Zynlonta (loncastuximab tesirine-lpyl) | Antibody-drug conjugate targeting CD19 | Relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy | ADC Therapeutics SA, of Lausanne, Switzerland | BLA | Accelerated; priority; NME | 4/23/21 |
Camcevi (leuprolide mesylate) | Subcutaneous depot version of GnRH agonist | Advanced prostate cancer | Foresee Pharmaceuticals Ltd., of Taipei, Taiwan | NDA | Standard | 5/26/21 |
Cosentyx (secukinumab) | Inhibits IL-17A | Moderate to severe plaque psoriasis | Novartis AG, of Basel, Switzerland | sBLA | N/A | 5/28/21 |
Empaveli (pegcetacoplan) | C3 therapy | Paroxysmal nocturnal hemoglobinuria | Apellis Pharmaceuticals Inc., of Waltham, Mass. | NDA | NME; priority; orphan | 5/14/21 |
Ferriprox (deferiprone) | Iron chelator | Transfusional iron overload | Chiesi Global Rare Diseases, a business unit of Parma, Italy-based Chiesi Farmaceutici SpA | sNDA | N/A | 5/1/21 |
Icatibant | Generic of Firazyr (Takeda Pharmaceutical Co. Ltd.) | Hereditary angioedema | Glenmark Pharmaceuticals Ltd., of Mumbai, India | ANDA | N/A | 5/24/21 |
Keytruda (pembrolizumab) | PD-1 inhibitor | Gastric or gastroesophageal junction adenocarcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | Accelerated | 5/5/21 |
Lumakras (sotorasib) | KRASG12C inhibitor | Non-small-cell lung cancer | Amgen Inc., of Thousand Oaks, Calif. | NDA | NME; priority | 5/28/21 |
Lybalvi (olanzapine and samidorphan) | Atypical antipsychotic | Schizophrenia and bipolar I disorder | Alkermes plc, of Dublin | NDA | NME; standard | 5/28/21 |
Myfembree (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) | GNRH receptor antagonist; estradiol agonist; progesterone receptor agonist | Uterine fibroids | Myovant Sciences Ltd., of Basel, Switzerland, and Pfizer Inc., of New York | NDA | Standard | 5/26/21 |
Nurtec ODT (rimegepant 75 mg) | Oral CGRP antagonist | Episodic migraine | Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. | sNDA | N/A | 5/27/21 |
Nuzyra (omadacycline) | Broad-spectrum aminomethylcycline antibiotic | Community-acquired bacterial pneumonia | Paratek Pharmaceuticals Inc., of Boston | sNDA | N/A | 5/27/21 |
Opdivo (nivolumab) | Monoclonal antibody targeting PD-1 | Esophageal or gastroesophageal junction cancer | Bristol Myers Squibb Co., of Princeton, N.J. | sBLA | N/A | 5/20/21 |
Pylarify (piflufolastat F 18) injection | F 18-labeled prostate-specific membrane antigen targeted PET imaging agent | Identification of metastasis or recurrence of prostate cancer | Lantheus Holdings Inc., of North Billerica, Mass. | NDA | Priority; NME | 5/27/21 |
Rybrevant (amivantamab) | EGFR and MET bispecific antibody | Non-small-cell lung cancer | Janssen Pharmaceutical Cos., part of New Brunswick, N.J.-based Johnson & Johnson | BLA | NME | 5/21/21 |
Truseltiq (infigratinib) | FGFR1-3 inhibitor | Cholangiocarcinoma | Bridgebio Pharma Inc. and QED Therapeutics Inc., both of Palo Alto, Calif. | NDA | Priority; NME; accelerated | 5/28/21 |
Zeposia (ozanimod) | S1P receptor modulator | Ulcerative colitis | Bristol Myers Squibb Co., of New York | sNDA | Priority | 5/27/21 |
Zynrelef (bupivacaine + meloxicam extended release) | Cyclooxygenase 2 inhibitor + sodium channel inhibitor | Pain | Heron Therapeutics Inc., of San Diego | NDA | Priority | 5/12/21 |
Aducanumab | Monoclonal antibody targeting amyloid-beta | Alzheimer’s disease | Biogen Inc., of Cambridge, Mass. | BLA | NME | 6/7/21 |
Ayvakit (avapritinib) | Kinase inhibitor | Advanced systemic mastocytosis | Blueprint Medicines Corp., of Cambridge, Mass. | sNDA | N/A | 6/16/21 |
Brexafemme (ibrexafungerp) | Antifungal | Vulvovaginal candidiasis | Scynexis Inc., of Jersey City, N.J. | NDA | NME; priority | 6/2/21 |
Brincidofovir | Antiviral | Smallpox | Chimerix Inc., of Durham, N.C. | NDA | Priority; orphan | 6/4/21 |
Epclusa (sofosbuvir and velpatasvir) | HCV NS5B polymerase inhibitor and HCV NS5A inhibitor | Chronic hepatitis C virus infection | Gilead Sciences Inc., of Foster City, Calif. | sNDA | N/A | 6/10/21 |
Kedrab (rabies immune globulin [human]) | Vaccine | Rabies prophylaxis | Kedrion Biopharma Inc., of Fort Lee, N.J., and Kamada Ltd., of Rehovot, Israel | sBLA | N/A | 6/2/21 |
PF-06482077, Prevnar 20, 20vPnC | 20-valent pneumococcal vaccine comprising polysaccharides of Streptococcus pneumoniae serotypes conjugated to diphtheria CRM197 | Streptococcus pneumoniae infection | Pfizer Inc., of New York | BLA | N/A | 6/9/21 |
Pradaxa (dabigatran etexilate) | Thrombin inhibitor | Venous thromboembolism | Boehringer Ingelheim GmbH, of Ingelheim, Germany | NDA | Priority | 6/21/21 |
Rezipres | Ephedrine hydrochloride injection | Hypotension | Eton Pharmaceuticals Inc., of Deer Park, Ill. | NDA | Standard | 6/15/21 |
Rylaze (JZP-458, asparaginase Erwinia chrysanthemi) | Recombinant crisantaspase produced using Pseudomonas fluorescens expression system | Acute lymphoblastic leukemia or lymphoblastic lymphoma | Jazz Pharmaceuticals plc, of Dublin | BLA | NME; orphan | 6/30/21 |
Ryplazim (plasminogen) | Plasmin stimulator | Congenital plasminogen deficiency | Liminal Biosciences Inc., of Laval, Quebec | BLA | N/A | 6/4/21 |
Trikafta | Fixed-dose combination pack of ivacaftor and elexacaftor, tezacaftor and ivacaftor; CFTR modulator | Cystic fibrosis | Vertex Pharmaceuticals Inc., of Boston | sNDA | N/A | 6/9/21 |
Ultomiris (ravulizumab) | Long-acting C5 inhibitor | Paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals Inc., of Boston | sBLA | Priority | 6/7/21 |
Verkazia | 0.1% eye drops of cyclosporine ophthalmic emulsion | Vernal keratoconjunctivitis | Santen Pharmaceutical Co. Ltd., of Osaka, Japan | NDA | Standard; orphan | 6/23/21 |
Wegovy (semaglutide, 2.4 mg injection) | GLP-1 receptor agonist | Obesity | Novo Nordisk A/S, of Bagsvaerd, Denmark | NDA | Priority | 6/8/21 |
Adhansia XR (methylphenidate hydrochloride) | Dopamine transporter inhibitor | Attention deficit hyperactivity disorder | Adlon Therapeutics LP, of Stamford, Conn., a subsidiary of Purdue Pharma LP | sNDA | N/A | 7/1/21 |
Aduhelm (aducanumab) | Human monoclonal IgG1 antibody anti-beta-amyloid | Alzheimer’s disease (updated - mild stages of disease) | Biogen Inc., of Cambridge, Mass. | sBLA | N/A | 7/8/21 |
Baclofen | Muscle relaxant | Muscle pain, spams and stiffness in patients with multiple sclerosis or spinal cord injury | Beximco Pharmaceuticals Ltd., of Dhaka, Bangladesh | ANDA | N/A | 7/16/21 |
Botox (onabotulinumtoxinA) | Acetylcholine release inhibitor | Upper limb spasticity in adults | Abbvie Inc., of North Chicago | sBLA | N/A | 7/28/21 |
Bydureon Bcise (exenatide, microsphere suspension formulation) | Exendin 4 ligand; GLP-1 receptor agonist | Type 2 diabetes (10 and older) | Astrazeneca plc, of Cambridge, U.K. | SNDA | N/A | 7/23/21 |
Bylvay (odevixibat) | Ileal bile acid transport inhibitor | Progressive familial intrahepatic cholestasis | Albireo Pharma Inc., of Boston | NDA | Priority; NME | 7/20/21 |
Dalvance (dalbavancin) | Semisynthetic lipoglycopeptide | Acute bacterial skin and skin structure infections | Abbvie Inc., of North Chicago | sNDA | N/A | 7/22/21 |
Darzalex Faspro (daratumumab and hyaluronidase-fihj) | Anti-CD38 monoclonal antibody | Multiple myeloma | Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson | sBLA | N/A | 7/12/21 |
Fexinidazole | Oral therapy | Human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | Sanofi SA, of Paris | NDA | Priority; orphan | 7/16/21 |
Kerendia (finerenone) | Mineralocorticoid receptor antagonist | Chronic kidney disease and type 2 diabetes | Bayer AG, of Leverkusen, Germany | NDA | Priority; NME | 7/9/21 |
Keytruda (pembrolizumab) | Anti-PD-1 humanized monoclonal antibody | Locally advanced cutaneous squamous cell carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 7/6/21 |
Keytruda (pembrolizumab) | Anti-PD-1 humanized monoclonal antibody | High-risk, early stage triple-negative breast cancer | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 7/26/21 |
Keytruda (pembrolizumab), Lenvima (lenvatinib) | Anti-PD-1 humanized monoclonal antibody; tyrosine kinase inhibitor | Microsatellite instability-high or mismatch repair deficient advanced endometrial cancer | Merck & Co. Inc., of Kenilworth, N.J., and Eisai Inc., of Woodcliff Lake, N.J. | sNDA | N/A | 7/22/21 |
Nucala (mepolizumab) | Monoclonal antibody targeting IL-5 | Chronic rhinosinusitis with nasal polyps | Glaxosmithkline plc, of London | sBLA | N/A | 7/29/21 |
Octagam | Liquid preparation of highly purified immunoglobulin G | Dermatomyositis | Octapharma AG, of Lachen, Switzerland | BLA | N/A | 7/20/21 |
Padcev (enfortumab vedotin-ejfv) | Antibody-drug conjugate consisting of monoclonal antibody targeting nectin-4 and microtubule-disrupting agent monomethyl auristatin E | Locally advanced or metastatic urothelial carcinoma | Seagen Inc., of Bothell, Wash., and Astellas Pharma Inc., of Tokyo | sBLA | N/A | 7/9/21 |
Prograf (tacrolimus) | Calcineurin-inhibitor; immunosuppressant | Organ rejection | Astellas Pharma Inc., of Tokyo | sNDA | N/A | 7/21/21 |
Rezurock (belumosudil) | Rho-associated coiled-coil kinase 2 inhibitor | Chronic graft-vs.-host disease | Kadmon Holdings Inc., of New York | NDA | Priority; NME; orphan | 7/16/21 |
Semglee (insulin glargine-yfgn) | Long acting insulin analogue | Diabetes mellitus | Viatris Inc., of Pittsburgh, and Biocon Biologics Ltd., of Bengaluru, India | sBLA | N/A | 7/28/21 |
Shingrix | Recombinant herpes zoster vaccine adjuvanted with AS01B | Herpes zoster (shingles) | Glaxosmithkline plc, of London | sBLA | N/A | 7/26/21 |
Solosec (secnidazole) | Anti-infective nitroimidazole | Trichomoniasis | Lupin Pharmaceuticals Inc., of Mumbai, India | sNDA | N/A | 7/1/21 |
Twyneo | Fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin | Acne vulgaris | Sol-Gel Technologies Ltd., of Ness Ziona, Israel | NDA | Standard | 7/26/21 |
Uptravi (selexipag) | Oral prostacyclin receptor agonist | Pulmonary arterial hypertension | Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson | NDA | Standard | 7/29/21 |
Vaxneuvance | Pneumococcal 15-valent conjugate vaccine | Prevention of invasive disease caused by Streptococcus pneumoniae serotypes | Merck & Co. Inc., of Kenilworth, N.J. | BLA | Priority | 7/16/21 |
Brivaracetam | Anticonvulsant | Partial-onset seizures | UCB SA, of Brussels | sNDA | N/A | 8/27/21 |
Comirnaty (Pfizer-Biontech COVID-19 vaccine) | mRNA vaccine | COVID-19 | Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany | BLA | N/A | 8/23/21 |
Difluprednate | Glucocorticoid receptor agonist | Anterior uveitis | Cipla Ltd., of Mumbai, India, | ANDA | N/A | 8/12/21 |
Gvoke | Glucagon injection | Severe hypoglycemia | Xeris Pharmaceuticals Inc., of Chicago | sNDA | N/A | 8/23/21 |
Jardiance (empagliflozin) | SGLT2 inhibitor | Heart failure with reduced ejection fraction | Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis | sNDA | N/A | 8/18/21 |
Jemperli (dostarlimab) | Anti-PD-1 antibody | Mismatch repair deficient recurrent or advanced solid tumors | Anaptysbio Inc., of San Diego, and Glaxosmithkline plc, of London | BLA | N/A | 8/17/21 |
Keytruda (pembrolizumab) | Anti-PD-1 | Advanced urothelial carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 8/31/21 |
Keytruda (pembrolizumab), Lenvima (lenvatinib) | Anti-PD-1 humanized monoclonal antibody; tyrosine kinase inhibitor | Advanced renal cell carcinoma | Merck & Co. Inc., of Kenilworth, N.J., and Eisai Inc., of Woodcliff Lake, N.J. | sBLA | Priority | 8/10/21 |
Korsuva (difelikefalin) | Opioid receptor kappa agonist | Moderate to severe pruritis in hemodialysis patients | Vifor Pharma Group, of St. Gallen, Switzerland, and Cara Therapeutics Inc., of Stamford, Conn. | NDA | Priority; NME | 8/23/21 |
Linzess (linaclotide) | Guanylate cyclase-C agonist | Irritable bowel syndrome with constipation and chronic idiopathic constipation | Ironwood Pharmaceuticals Inc., of Boston | sNDA | N/A | 8/26/21 |
Lyumjev (insulin lispro-aabc) and Omnipod | Rapid-acting insulin | Type 1 and type 2 diabetes | Eli Lilly and Co., of Indianapolis, and Insulet Corp., of Acton, Mass. | sBLA | N/A | 8/13/21 |
Nexviazyme (avalglucosidase alfa) | Enzyme replacement therapy to target mannose-6-phosphate receptor | Pompe disease | Sanofi SA, of Paris | BLA | Orphan | 8/6/21 |
Opdivo (nivolumab) | Human monoclonal antibody targeting PD-1 | High-risk urothelial carcinoma | Bristol Myers Squibb Co., of New York | sBLA | N/A | 8/20/21 |
Saphnelo (anifrolumab-fnia) | Fully human monoclonal antibody that binds to subunit 1 of type I IFN receptor | Moderate to severe systemic lupus erythematosus | Astrazeneca plc, of Cambridge, U.K. | BLA | N/A | 8/2/21 |
Skytrofa (lonapegsomatropin-tcgd) | Long-acting prodrug of somatropin | Pediatric growth hormone deficiency | Ascendis Pharma A/S, of Copenhagen | BLA | N/A | 8/25/21 |
Tibsovo (ivosidenib) | Oral L-prolinamide-derived inhibitor of isocitrate dehydrogenase 1 | IDH1-mutated cholangiocarcinoma | Servier Pharmaceuticals, of Boston, part of Servier Group | sNDA | N/A | 8/25/21 |
TicoVac | Inactivated whole virus vaccine | Tick-borne encephalitis | Pfizer Inc., of New York | BLA | Priority | 8/16/21 |
Welireg (belzutifan; MK-6482) | HIF-2 alpha Inhibitor | Von Hippel-Lindau disease-associated cancers | Merck & Co. Inc., of Kenilworth, N.J. | NDA | Priority; NME; orphan | 8/13/21 |
Xarelto (rivaroxaban) | Oral factor Xa inhibitor | Peripheral artery disease (following lower-extremity revascularization) | Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson | SNDA | N/A | 8/24/21 |
Xywav (calcium, magnesium, potassium and sodium oxybates) | GABA B receptor agonist | Idiopathic hypersomnia | Jazz Pharmaceuticals Inc. plc, of Dublin | sNDA | Priority | 8/12/21 |
Xywav (calcium, magnesium, potassium and sodium oxybates) | GABA B receptor agonist | Cataplexy or excessive daytime sleepiness (7 and older) | Jazz Pharmaceuticals Inc. plc, of Dublin | sNDA | N/A | 8/12/21 |
Brukinsa (zanubrutinib) | BTK inhibitor | Waldenström’s macroglobulinemia | Beigene Ltd., of Beijing | sNDA | N/A | 9/1/21 |
Brukinsa (zanubrutinib) | BTK inhibitor | Relapsed or refractory marginal zone lymphoma | Beigene Ltd., of Beijing | sNDA | Accelerated; priority | 9/15/21 |
Cabometyx (cabozantinib) | Kinase inhibitor | Locally advanced or metastatic differentiated thyroid cancer | Exelixis Inc., of Alameda, Calif. | sNDA | N/A | 9/17/21 |
Erbitux (cetuximab) | Anti-EGFR antibody | Metastatic colorectal cancer | Eli Lilly and Co., of Indianapolis | sBLA | N/A | 9/28/21 |
Exkivity (mobocertinib) | Selectively targets EGFR exon 20 insertion mutations | Non-small-cell lung cancer | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | NDA | Priority; NME; orphan | 9/15/21 |
Humira (adalimumab) | Human anti-TNF-alpha monoclonal antibody | Ulcerative colitis | Eisai Co. Ltd., of Tokyo, and Abbvie Inc., of North Chicago, Ill. | sBLA | N/A | 9/27/21 |
INP-104 | Dihydroergotamine mesylate | Acute migraine headaches with or without aura in adults | Impel Neuropharma Inc., of Seattle | NDA | N/A | 9/3/21 |
Invega Hafyera | 6-month paliperidone palmitate | Schizophrenia | Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J. | sNDA | N/A | 9/1/21 |
Jakafi (ruxolitinib) | JAK1/JAK2 inhibitor | Graft-vs.-host disease | Incyte Corp., of Wilmington, Del. | sNDA | N/A | 9/22/21 |
Lexette (halobetasol propionate 0.05%) | Topical corticosteroid | Plaque psoriasis | Mayne Pharma Group Ltd., of Adelaide, Australia | sNDA | N/A | 9/21/21 |
Livmarli (maralixibat) | Apical sodium dependent bile acid transporter | Alagille syndrome | Mirum Pharmaceuticals Inc., of Foster City, Calif. | NDA | Priority; NME | 9/29/21 |
Norepinephrine | Norepinephrine bitartrate in 5% Dextrose injection | Hypotension | Baxter International Inc., of Deerfield, Ill. | NDA | N/A | 9/23/21 |
Opzelura (ruxolitinib) | JAK1/JAK2 inhibitor; topical cream | Mild to moderate atopic dermatitis | Incyte Corp., of Wilmington, Del. | NDA | Priority | 9/21/21 |
Qulipta (atogepant) | CGRP antagonist | Migraine | Abbvie Inc., of North Chicago | NDA | Priority; NME | 9/28/21 |
Repatha (evolocumab) | Human monoclonal antibody that inhibits PCSK9 | Heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia | Amgen Inc., of Thousand Oaks, Calif. | sBLA | N/A | 9/24/21 |
SB-11 | Anti-VEGF; biosimilar of Lucentis (ranibizumab) | Neovascular age-related macular degeneration, macular edema and myopic choroidal neovascularization | Samsung Bioepis Co. Ltd., of Incheon, Korea, and Biogen Inc., of Cambridge, Mass. | BLA | N/A | 9/20/21 |
Tivdak (tisotumab vedotin) | Antibody-drug conjugate targeting tissue factor | Recurrent or metastatic cervical cancer | Genmab A/S, of Copenhagen, Denmark, and Seagen Inc., of Bothell, Wash. | BLA | Accelerated; priority; NME | 9/20/21 |
Vonoprazan | Potassium-competitive acid blocker | H. pylori infection | Phathom Pharmaceuticals Inc., of Florham Park, N.J. | NDA | N/A | 9/8/21 |
Cyltezo (adalimumab-adbm) | TNF blocker | Multiple chronic inflammatory diseases | Boehringer Ingelheim Pharmaceuticals Inc., a unit of Boehringer Ingelheim GmbH, of Ingelheim, Germany | sBLA | N/A | 10/15/21 |
Dextenza (dexamethasone ophthalmic insert) | Glucocorticoid receptor agonist | Ocular itching associated with allergic conjunctivitis | Ocular Therapeutix Inc., of Bedford, Mass. | sNDA | N/A | 10/11/21 |
Dupixent (dupilumab) | Human monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13 proteins | Moderate to severe asthma | Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | N/A | 10/20/21 |
Keytruda (pembrolizumab) | Anti-PD-1 antibody | Cervical cancer | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 10/13/21 |
Rethymic | Allogeneic processed thymus tissue-agdc; regenerative tissue-based therapy | Immune reconstitution in pediatric patients with congenital athymia | Enzyvant Therapeutics Inc., of Cambridge, Mass. | BLA | N/A | 10/8/21 |
Rexulti (brexpiprazole) | Partial agonist of serotonin 5-HT1A and dopamine D2 receptors | Schizophrenia | Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Valby, Denmark | sNDA | N/A | 10/13/21 |
Scemblix (asciminib) | STAMP inhibitor | Chronic myeloid leukemia | Novartis AG, of Basel, Switzerland | NDA | Accelerated; priority; orphan; NME | 10/29/21 |
Seglentis | Combination of celecoxib and tramadol; co-crystal form | Acute pain | Esteve Pharmaceuticals SA, of Barcelona, Spain | NDA | N/A | 10/15/21 |
Tavneos (avacopan) | Complement 5a receptor inhibitor | Vasculitis | Chemocentryx Inc., of Mountain View, Calif. | NDA | NME | 10/8/21 |
Tecartus (brexucabtagene autoleucel) | CAR T therapy | Relapsed or refractory B-cell precursor acute lymphoblastic leukemia | Kite, of Santa Monica, Calif., a Gilead Co. | sBLA | Priority | 10/1/21 |
Tecentriq (atezolizumab) | Monoclonal antibody targeting PD-L1 | Non-small-cell-lung cancer | Roche Holding AG, of Basel, Switzerland | sBLA | N/A | 10/15/21 |
Tyrvaya (varenicline solution) | Nasal spray 0.03 mg | Dry eye disease | Oyster Point Pharma Inc., of Princeton, N.J. | NDA | Standard | 10/15/21 |
Verzenio (abemaciclib) | CDK4/6 inhibitor | High-risk, early breast cancer | Eli Lilly and Co., of Indianapolis | sNDA | N/A | 10/13/21 |
Vuity (pilocarpine HCl ophthalmic solution) 1.25% | Muscarinic cholinergic agonist | Presbyopia | Abbvie Inc., of North Chicago | NDA | Standard | 10/28/21 |
Xipere (triamcinolone acetonide suprachoroidal injectable suspension) | Glucocorticoid receptor agonist | Macular edema associated with uveitis | Bausch Health Cos. Inc., of Laval, Quebec, and Clearside Biomedical Inc., of Alpharetta, Ga. | sNDA | N/A | 10/25/21 |
Zimhi | Naloxone HCL injection, 5 mg/0.5 mL product; opioid antagonist | Opioid overdose | Adamis Pharmaceuticals Corp., of San Diego | NDA | Standard | 10/18/21 |
Audenz (influenza A [H5N1] monovalent vaccine) | Cell-based influenza vaccines using the MF59 adjuvant | Influenza virus infection | Seqirus Inc., of Holly Springs, N.C., a unit of CSL Ltd., of Melbourne, Australia | sBLA | N/A | 11/23/21 |
Besremi (ropeginterferon alfa-2b-njft) | Monopegylated, long-acting interferon | Polycythemia vera | Pharmaessentia Corp., of Burlington, Mass. | BLA | NME | 11/12/21 |
Cytalux (pafolacianine) | Fluorescent imaging agent | Diagnosis of ovarian cancer lesions | On Target Laboratories Inc., of West Lafayette, Ind. | NDA | Priority; orphan; NME | 11/29/21 |
Darzalex Faspro (daratumumab and hyaluronidase-fihj) | ADP ribosyl cyclase-1 inhibitor | Relapsed or refractory multiple myeloma | Amgen Inc., of Thousand Oaks, Calif., and Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J. | sBLA | N/A | 11/30/21 |
Dyanavel XR (amphetamine) | Extended-release once-daily tablets | Attention deficit hyperactivity disorder | Tris Pharma Inc., of Monmouth Junction, N.J. | sNDA | N/A | 11/4/21 |
Eprontia | Topiramate oral solution | Partial-onset or primary generalized tonic-clonic seizures | Eton Pharmaceuticals Inc., of Deer Park, Ill., and Azurity Pharmaceuticals Inc., of Woburn, Mass. | NDA | Standard | 11/5/21 |
Fyarro (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) | mTOR inhibitor | Locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor | Aadi Bioscience Inc., of Los Angeles | NDA | Priority; orphan | 11/22/21 |
Keytruda (pembrolizumab) | Anti-PD-1 therapy | Renal cell carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 11/18/21 |
Lyvispah | Baclofen oral granules | Spasticity | Saol Therapeutics Inc., of Roswell, Ga., | NDA | Standard | 11/22/21 |
Purified Cortrophin Gel (repository corticotrophin injection USP) | Adrenocorticotropic hormone | Chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome | ANI Pharmaceuticals Inc., of Baudette, Minn. | sNDA | N/A | 11/1/21 |
TAK-620 (maribavir) | Serine/threonine protein kinase UL97 (viral) inhibitor | Refractory cytomegalovirus infection/disease and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | NDA | Priority; orphan; NME | 11/23/21 |
Voxzogo (vosoritide) | Analogue of C-type natriuretic peptide | Achondroplasia | Biomarin Pharmaceutical Inc., of San Rafael, Calif. | NDA | Accelerated; priority; orphan; NME | 11/19/21 |
Yutrepia | Treprostinil inhalation powder | Pulmonary arterial hypertension | Liquidia Corp., of Morrisville, N.C. | ANDA | N/A | 11/8/21 |
Abatacept (Orencia) | Selective modulator of a co-stimulatory signal required for full T-cell activation | Moderate to severe acute graft-vs.-host disease | Bristol Myers Squibb Co., of New York | sBLA | Priority | 12/15/21 |
Adbry (tralokinumab-ldrm) | Human monoclonal antibody developed to neutralize the IL-13 cytokine | Moderate to severe atopic dermatitis | Leo Pharma Inc., of Madison, N.J. | BLA | NME | 12/28/21 |
Apretude | Cabotegravir extended-release injectable suspension | HIV-1 infection | Viiv Healthcare Ltd., of London | NDA | Priority | 12/21/21 |
Caplyta (lumateperone) | Combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity | Bipolar depression | Intra-Cellular Therapies Inc., of New York | sNDA | N/A | 12/17/21 |
Cosentyx (secukinumab) | Inhibits IL-17A | Active enthesitis-related arthritis and active juvenile psoriatic arthritis | Novartis AG, of Basel, Switzerland | sBLA | N/A | 12/22/21 |
Cutaquiq | Immune globulin, subcutaneous (human) 15.6% solution | Primary humoral immunodeficiency | Octapharma USA, of Paramus, N.J. | sBLA | N/A | 12/7/21 |
DARE-BV1 | Thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% | Bacterial vaginosis | Daré Bioscience Inc., of San Diego | NDA | Priority | 12/7/21 |
Dartisla | Glycopyrrolate tablets | Peptic ulcer | Edenbridge Pharmaceuticals LLC., of Parsippany, N.J. | NDA | Standard | 12/16/21 |
Entadfi | Finasteride and tadalafil oral capsule | Urinary tract symptoms caused by benign prostatic hyperplasia | Veru Inc., of Miami | NDA | Standard | 12/9/21 |
Illuccix (TLX591-Cdx) | 68Ga PSMA-11 injection | Prostate cancer imaging agent | Telix Pharmaceuticals Ltd., of Melbourne, Australia | NDA | Standard | 12/17/21 |
Injectafer (ferric carboxymaltose injection) | Iron replacement product | Iron deficiency anemia | Daiichi Sankyo Co. Ltd., of Tokyo | sNDA | N/A | 12/16/21 |
Keytruda (pembrolizumab) | Anti-PD-1 antibody | Stage IIb or IIc melanoma | Merck & Co. Inc., of Kenilworth, N.J. | sBLA | N/A | 12/3/21 |
Leqvio (inclisiran) | siRNA therapy | Low-density lipoprotein cholesterol | Novartis AG, of Basel, Switzerland, and Alnylam Pharmaceutical Inc., of Cambridge, Mass. | NDA | NME; standard | 12/22/21 |
Otezla (apremilast) | Oral small-molecule inhibitor of phosphodiesterase 4 | Plaque psoriasis | Amgen Inc., of Thousand Oaks, Calif. | sNDA | N/A | 12/20/21 |
Prehevbrio | Recombinant hepatitis B vaccine containing S, pre-S2, and pre-S1 HBV surface antigens | Hepatitis B virus infection | VBI Vaccines Inc., of Cambridge, Mass | BLA | N/A | 12/1/21 |
Recorlev (levoketoconazole) | Adrenal steroidogenesis inhibitor | Cushing's syndrome | Xeris Biopharma Holdings Inc., of Chicago | NDA | Orphan | 12/31/21 |
Rezvoglar (insulin glargine-aglr) | Biosimilar Lantus; long-acting human insulin derivative | Diabetes mellitus | Eli Lilly and Co., of Indianapolis | BLA | N/A | 12/21/21 |
Rinvoq (upadacitinib) | JAK inhibitor | Psoriatic arthritis | Abbvie Inc., of North Chicago | sNDA | N/A | 12/14/21 |
Tarpeyo | Oral formulation targeting down-regulation of IgA1 | Primary IgA nephropathy | Calliditas Therapeutics AB, of Stockholm | NDA | Accelerated; priority | 12/15/21 |
Tezspire (tezepelumab-ekko) | Human monoclonal antibody against human thymic stromal lymphopoietin | Asthma | Astrazeneca plc, of Cambridge, U.K., and Amgen Inc., of Thousand Oaks, Calif. | BLA | Priority; NME | 12/17/21 |
Vyvgart (efgartigimod; ARGX-113) | Antibody fragment targeting neonatal Fc receptor | Generalized myasthenia gravis | Argenx SE, of Breda, the Netherlands | NDA | NME | 12/17/21 |
Xaciato | clindamycin phosphate vaginal gel, 2% | Bacterial vaginosis | Dare Bioscience Inc., of San Diego | NDA | Priority | 12/7/21 |
Xarelto (rivaroxaban) | Oral factor Xa inhibitor | Venous thromboembolism (VTE) and reduction of recurrent VTE | Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson | NDA | Priority | 12/20/21 |
Xeljanz / Xeljanz XR (tofacitinib) | Oral JAK inhibitor | Ankylosing spondylitis | Pfizer Inc., of New York | sNDA | N/A | 12/14/21 |
Yusimry (CHS-1420, adalimumab-aqvh) | Adalimumab biosimilar/TNF blocker | Plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis | Coherus Biosciences Inc., of Redwood city, Calif. | BLA | N/A | 12/20/21 |