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Orchid receives FDA approval for antibiotic drug

The pharma major receives approval from the US FDA for its abbreviated new drug application for Cefepime injection.

business Updated: Jun 21, 2007 18:37 IST

Pharma major Orchid Chemicals and Pharmaceuticals Ltd has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Cefepime injection.

Cefepime injection is a life saving cephalosporin antibiotic drug with an annual sale of $190 million, and is used in hospital settings.

"Orchid's Cefepime approval for the US generic market is prestigious, given that it is the first abbreviated new drug application (ANDA) approval received for this product from the FDA.

The product has been supplied to Apotex for distribution by them in the US," Orchid's Managing Director K Raghavendra Rao said here on Thursday.

The product is available in three dosage strengths, 500 mg/vial, 1 gram/vial, and 2 grams/vial.

The Chennai-based Orchid has filed 40 ANDAs comprising 29 antibiotic and 11 non-antibiotic products so far with the FDA. It has received approvals for 19 ANDAs, including Cefepime.