Orchid Chemicals & Pharmaceuticals Ltd has received the formal approval from the US FDA for its abbreviated new drug application (ANDA) for cefoxitin for injection, 1 gm/vial and 2 gm/vial.
Cefoxitin is the generic version of Merck's Mefoxin. The company is launching this product in the US exclusively through Apotex, claims the company release.
"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," said K Raghavendra Rao, managing director, Orchid.
The company has till date filed 21 ANDAs and 26 DMFs.