Orchid gets US FDA approval for antibiotic generic, Cefepime

New Delhi, June 21 (UNI) Pharma company Orchid Chemicals and Pharmaceuticals Ltd today said it has received approval from the US FDA for its ANDA for Cefepime injection in the strength of 500 mg, 1g and 2g.

Cefepime injection is a life saving cephalosporin antibiotic drug used in hospital setting. The brand product has a recorded sale of 190 million dollars over a 12-month period, a statement said.

The company's Managing Director K Raghavendra Rao, said ''Orchid's Cefepime approval for the US generic market is prestigious given that it is the first ANDA approval received for this product from the US FDA. The product has been supplied to Apotex for distribution by them in the US.'' Orchid has, till date, filed 40 ANDAs including the Cefepime approval just received. The company has received approvals for 19 ANDAs from the US FDA.

UNI