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.

Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet (PR Newswire via Yahoo! Finance)
Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Pamlab's Palgic 4mg Tablet .

Abiomed Receives 510(k) Clearance from FDA for Impella 2.5 Device (Centre Daily Times)
Abiomed, Inc. (NASDAQ: ABMD) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Impella 2.5 Cardiac Assist Device. This 510(k) clearance allows Abiomed to begin selling the device to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.