Orchid chemicals receives USFDA approval for Terbinafine

Mumbai, June 15 (UNI) Pharma major Orchid Chemicals today announced it has received tentative approval from US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Terbinafine HCL 250mg 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.

''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,'' Company managing director Raghavendra Rao said in a communique to the Bombay Stock Exchange (BSE).

Terbinafine has a current US retail market size of USD 650 million, and Orchid plans to launch this product in the US market through its distribution partner, Actavis, after it's patent expires at the end of this month.

UNI