Alimera Sciences Inc., of Atlanta
Iluvien (fluocinolone acetonide intravitreal implant)
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
Ascletis Pharma Inc., of Hangzhou, China
Single-pill, once-daily fixed-dose antiviral combination
Hepatitis C virus
Received IND approval from China's NMPA
Daiichi Sankyo Co. Ltd., of Tokyo
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
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan
Schizophrenia and bipolar depression
Submitted NDA for approval in Japan
Vivus Inc., of Campbell, Calif.
Qsymia (phentermine and topiramate extended release)
Approved by South Korea Ministry of Food and Drug Safety; marketed in South Korea by partner Alvogen Korea Ltd.
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.