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Natco Pharma gains on USFDA nod for generic Bendamustine HCL powder

By
Natco Pharma , Financial results

Mumbai: Natco Pharma has moved higher by 6% to Rs 632 on the BSE in intra-day trade after the company said it has received final approval from US Food and Drug Administration (USFDA) for Bendamustine injection.

“The company has received final approval for abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the USFDA for generic version of Bendamustine Hydrochloride powder for injection, 25 mg/vial and 100 mg/vial (Singe-Dose Vial),” Natco Pharma said in a press release.

The company plans to launch this drug on November 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the US 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.

Cephalon sells Bendamustine Hydrochloride powder for injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial) under Brand name Treanda in the US market.

Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma.

According to IMS Health, Treanda had US sales of approximately USD 133 million for twelve months ending November, 2016.

At 02:13 pm; the stock was up 5% at Rs 629 as compared to 0.09% fall in the S&P BSE Sensex. A combined 962,143 shares changed hands on the counter on the BSE and NSE so far.

 

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