Three Indian drug firms get FDA nod

Aurobindo Pharma, Sun Pharma and Glenmark Pharmaceuticals have received USFDA approval for selling Rosuvastatin Calcium tablet, the generic version of IPR Pharmaceuticals cholesterol drug Crestor. Announcing that it has got USFDA approval to manufacture and market the antihyperlipidemic drug, Aurobindo Pharma said it was one of the first Abbreviated New Drug Application applicants to submit a substantially complete ANDA with a paragraph IV certification. Sun Pharmaceutical said one of its subsidiaries had received final approval from USFDA for its (ANDA) for generic version of Crestor. Glenmark Pharmaceuticals also made an announcement on receipt of final approval from the U.S. regulator. — Special Correspondent