Anda Approval

USFDA to fast-track review of generics tested and made in US, but do Indian drugmakers need to worry?

The move is part of a broader push to onshore pharmaceutical production and reduce reliance on foreign suppliers, particularly from India and China.

Glenmark gets US nod for alcohol dependence treatment drug

Glenmark's Acamprosate Calcium delayed release tablets are a generic version of Forest Labs' Campral. The drug had sales of USD 21 million for 12-months ended March 2013, according to IMS Health data.

Unichem Labs gets US FDA nod for muscle relaxant Tizanidine

Pharmaceutical company Unichem Laboratories has received abbreviated new drug approval (ANDA) from US Food and Drugs Administration for a copy of Tizanidine tablets, used as a muscle relaxant. The news sent its shares up over 2 percent in afternoon trade.