Civica Rx and 18 independent Blue Cross and Blue Shield (BCBS) companies formed a new subsidiary dedicated to lowering the cost of select generic drugs.
The U.S. Food and Drug Administration intends to pull nearly 250 Abbreviated New Drug Applications (ANDAs) following the failure of manufacturers to submit annual reports.
The U.S. Food and Drug Administration reported 1,171 generic drug approvals (935 full approvals and 236 tentative approvals) for fiscal year 2019, up from the previous all-time record total of 971 during 2018.
“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.
The FDA approved Mylan’s Estradiol Vaginal Cream USP 0.01%, the first generic version of Allergan’s Estrace.
The U.S. FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.
The U.S. FDA granted final approval to Aurobindo Pharma Limited’s generic treatment for multiple sclerosis.
The U.S. Food and Drug Administration approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc’s drug to treat patients with narcolepsy, a kind of sleeping disorder.
Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Memantine Hydrochloride Tablets USP, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent […]