USFDA approves Orchid's Cefotaxime injections

New Delhi, Aug 16: Orchid Chemicals and Pharmaceuticals Ltd today said it has received the formal approvals from the United States Food and Drug Administration (USFDA) for three of its Abbreviated New Drug Applications (ANDAs) for Cefotaxime injections.

The approvals have been received for various dosage forms of the drug, which is the generic version of Sanofi Aventis' Claforan.

The company would be launching this product in the US through its exclusive distribution partner, Apotex.

'The approvals for the Cefotaxime ANDAs mark another milestone in the company's efforts to offer a full-line injectable produce range in the US generic market. Though a mature off- patent product, Cefotaxime has limited competition thus enabling a notable market-share and revenue stream,'' a company statement said.

Orchid Chemicals has filed 31 ANDAs with the USFDA till date and the number of ANDAs approved by the USFDA stands at 15.

UNI