The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd has received approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Cefepime injection. The product is available in three dosage strengths, 500 mg/vial, 1 gram/vial, and 2 grams/vial.
Cefepime injection is a life saving cephalosporin antibiotic drug used in hospital setting. The brand product has a recorded sale of USD 190 million over a 12-month period.
Commenting on the approval, Orchid'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 comprising 29 antibiotic and 11 non-antibiotic products. Including the cefepime approval just received, Orchid has received approvals for 19 ANDAs from the US FDA.