The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, and Eli Lilly and Company announced.

Glenmark Pharmaceuticals Ltd. said its subsidiary Glenmark Generic Inc. USA, has obtained ANDA approval from the US FDA for Lithium Carbonate 150 mg, 300mg and 600 mg capsules.

Japan-based Takeda Pharma -ceutical's wholly-owned subsidiary, Takeda Pharma -ceuticals North America, has received approval from the US Food and Drug Administration (FDA) for Kapidex (dexlansoprazole), a once-daily delayed release capsules.

Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Divalproex sodium Extended-release (Divalproex ER) tablets, 250 mg and 500 mg.