The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received the tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250 mg Tablets. This is the first ANDA approval received by the company in the non-penicillin, non-cephalosporin (NPNC) space.

Terbinafine is the AB-rated generic equivalent of Novartis’s Lamisil Tablets. An anti-fungal molecule, Terbinafine has a current US retail market size of USD 650 million. Orchid plans to launch this product in the US market through its distribution partner, Actavis upon patent expiry on June 30, 2007.

“We are happy about our first non-antibiotic product approval. Based on this timely approval, we would be launching the product in the US and hope to garner a good market share and revenues given the market standing of our distribution partner, Actavis. Though, the non-antibiotic space is relatively more crowded than the antibiotic product space, we are focusing on a niche product basket involving stringent development and manufacturing challenges which would help in a better market presence”, said Mr K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd.

Sourced From: Orchid Chemicals & Pharmaceuticals Ltd