Lupin gets tentative approval from FDA (Business Standard India)
Pharmaceutical major Lupin Ltd has received tentative approval for its marketing application for a generic version of Topiramate tablets in four dosages from the US drug regulator, Food and Drug Administration (FDA).

The Medicines Company Receives FDA Review Letter For Angiomax Supplemental Filing (Medical News Today)
The Medicines Company (NASDAQ: MDCO) announced receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) on a supplemental New Drug Application (sNDA) for an additional dosing regimen for Angiomax (bivalirudin) in the treatment of acute coronary syndromes (ACS) initiated in the emergency department.

Lupin gets US FDA tentative nod for topiramate pills (PharmaBiz)
Lupin Ltd. has received tentative approval for the company's abbreviated new drug application (ANDA) for topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the US Food and Drug Administration (US FDA).