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NATCO receives final approval for Generic Bendamustine HCl Powder for USA Market

| | Jan 06, 2017, at 09:47 pm
New Delhi, Jan 6 (IBNS):Natco Pharma Limited on Friday announced the final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial).

Pursuant to the settlement of the Paragraph IV litigation, NATCO plans to launch this drug on Nov 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the USA market.

Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers, read the company's statement.

 

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