Alimera Sciences Inc., of Atlanta

Iluvien (fluocinolone acetonide intravitreal implant)

Corticosteroid

Diabetic macular edema

Approved by Australian Therapeutic Goods Administration for use in patients previously treated with a course of corticosteroids who did not have clinically significant rise in intraocular pressure

8/5/19

Ascletis Pharma Inc., of Hangzhou, China

ASC-18

Single-pill, once-daily fixed-dose antiviral combination

Hepatitis C virus

Received IND approval from China's NMPA

8/5/19

Daiichi Sankyo Co. Ltd., of Tokyo

Turalio (pexidartinib)

CSF1R inhibitor

Tenosynovial giant cell tumor

FDA approved for use in adults with symptomatic TGCT associated with severe morbidity or functional limitations and not responsive to improvement with surgery

8/2/19

Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan

Lurasidone hydrochloride

Atypical antipsychotic

Schizophrenia and bipolar depression

Submitted NDA for approval in Japan

8/1/19

Vivus Inc., of Campbell, Calif.

Qsymia (phentermine and topiramate extended release)

Anti-obesity compound

Weight loss

Approved by South Korea Ministry of Food and Drug Safety; marketed in South Korea by partner Alvogen Korea Ltd.

8/5/19

Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

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