Orchid gets ANDA`s final nod from USFDA for Zaleplon Capsules

Last Updated: Friday, September 18, 2009 - 14:03

Mumbai: Pharma firm Orchid Chemicals & Pharmaceuticals on Friday 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.

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.

Bureau Report



First Published: Friday, September 18, 2009 - 14:03

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