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USFDA approves Orchid's Cefoxitin

Orchid Chemicals & Pharmaceuticals has received USFDA approval for its ANDA for the antibiotic, Cefoxitin, 1 gm/vial and 2 gm/vial.

india Updated: Jan 27, 2006 13:44 IST

Pharmaceutical major Orchid Chemicals & Pharmaceuticals Ltd has received USFDA approval for its Abbreviated New Drug Application (ANDA) for the antibiotic, Cefoxitin, 1 gm/vial and 2 gm/vial.

The company is launching Cefoxitin, which is the generic version of Merck's Mefoxin, in the US market exclusively through Apotex, a leading Canadian generic pharmaceuticals company.

"We are extremely happy about this product approval. Though Cefoxitin has been off-patent for a while, Orchid is the second generic company to enter this product space and, hence, we expect a good market-share and revenues," Orchid Chemicals Managing Director K Raghavendra Rao said.

Orchid Chemicals informed the Stock Exchanges that till date it has filed 21 ANDAs and 26 DMFs (Drug Master Files).

This approved product belongs to a group of antibiotics called the cephalosporins, which kill bacteria by interfering with the ability of bacteria to form cell walls.

Cefoxitin, given by injection or infusion, is generally used in severe infections or before an operation to prevent infection after surgery.

First Published: Jan 27, 2006 13:44 IST