Assertio Therapeutics Inc., of Lake Forest, Ill.

Long-acting cosyntropin

Synthetic adrenocorticotropic hormone

Diagnostic drug to screen for adrenocortical insufficiency

FDA issued a complete response letter; primary focus relates to agency determination that certain pharmacodynamic parameters were not adequately achieved

Astrazeneca plc, of Cambridge, U.K.

Farxiga (dapagliflozin)

SGLT2 inhibitor

Type 2 diabetes

FDA approved expanded use to reduce risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors

Foamix Pharmaceuticals Ltd., of Rehovot, Israel

Amzeeq (FMX-101)

Minocycline topical foam 4%

Inflammatory lesions of non-nodular moderate to severe acne vulgaris

Approved by FDA for use in adults and pediatric patients, 9 and older

Janssen Pharmaceutical Cos., of New Brunswick, N.J.-based Johnson & Johnson

Stelara (ustekinumab)

Targets IL-12 and IL-23

Moderately to severely active ulcerative colitis

FDA expanded approval

Reveragen Biopharma Inc., of Rockville, Md.

Vamorolone

Dissociative steroid

Duchenne muscular dystrophy

Designated a promising innovative medicine by U.K.'s Medicines and Healthcare Products Regulatory Agency

Solasia Pharma KK, of Tokyo

Episil (SP-03)

Oral liquid

Oral mucositis

Approved by the National Institute of Medical Device Safety Information in South Korea for management of pain and relief of pain in oral cavity caused by chemotherapy and/or radiotherapy

Sophiris Bio Inc., of San Diego

Topsalysin (PRX-302)

Pore-forming protein

Intermediate-risk localized prostate cancer

Following end-of-phase II/pre-phase III meeting with FDA, reached agreement on phase III design to enroll about 700 patients to test topsalysin against placebo, with primary endpoint of proportion of patients at 12 months who have failed treatment, defined as histological progression of disease, resulting in the need for alternative therapy

United Therapeutics Corp., of Silver Spring, Md.

Orenitram (treprostinil) extended-release tablets

Prostacyclin mimetic

Pulmonary arterial hypertension

FDA approved supplemental NDA reflecting data from Freedom-EV study, to include that Orenitram delays disease progression when used in conjunction with approved oral background PAH therapy

Notes

For more information about individual companies and/or products, see Cortellis.