Orchid receives tentative US FDA NOD for Terbinafine HCL tablets

New Delhi, June 15 (UNI) Integrated pharmaceutical company Orchid Chemicals and Pharmaceuticals Ltd today said it has received tentative approval from the US Food and Drug Administration (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, a statement said.

Terbinafine is the AB-rated generic equivalent of Novartis's Lamisil tablets.

''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 antibiotics product space. We are focusing on a niche product basket involving stringent development and manufacturing challenges which would help in a better market presence,'' company's Managing Director K Raghavenda Rao said.

An anti-fungal molecule, Terbinafine has a current US retail market size of 650 million dollar. The company plans to launch this product in the US market through its distribution partner, Actavis upon patent expiry on June 30.

UNI