Orchid gets USFDA nod for non-antibiotic drug

Chennai-based drug major Orchid Chemicals & Pharmaceuticals has received approval from US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Granisetron Hydrochloride tablets in one mg dosage.

According to a release issued by Orchid to the BSE today, it is the first Indian company to get approval for the non-antibiotic product. Granisetron hydrochloride, known by the brand Kytril of drug major Roche, is used in the treatment of side effects like nausea related to chemotherapy.

The US drug regulator has given genric approvals for the drug to companies like Mylan, Teva, Barr Pharmaceuticals and Abraxis. Cipla also has a tentative approval from USFDA to manufacture and market the drug.