Business IdeasOrchid gets ANDA's final nod from USFDA for Zaleplon Capsules
Pharma firm Orchid Chemicals & Pharmaceuticals today said it has received the final Abbreviated New Drug Application (ANDA) approval for its Zaleplon capsules from the US Food and Drug Administration, in a filing to the Bombay Stock Exchange(BSE).
- Suven in talks with global drug makers for licensing deal: CEO - Wockhardt divests animal health division - Orchid Pharma settles patent row, stock up 4% - Orchid Pharma settles patent row with Schering-Plough - Ranbaxy, Aurobindo get USFDA nod for migraine drug - Ranbaxy gets GMP approval from Japan
The capsules are in strengths of 5 mg and 10 mg and are used in treating insomnia, the filing added.
With this approval, the total ANDA approval count of Orchid has gone up to 37 while the total ANDA filings stand at 58, it added.
Earlier, on September 16, the pharma firm had received the US drug regulator"s nod for its Piperacillin and Tazobactam injection used to treat infections caused by certain bacteria and accordingly had been granted 180-days generic drug exclusivity.