USFDA nod for Natco’s anti-cancer drug

June 27, 2017 09:17 pm | Updated July 08, 2017 04:36 pm IST

A private security guard looks out from a window of the head office of Natco in the southern Indian city of Hyderabad March 13, 2012.

A private security guard looks out from a window of the head office of Natco in the southern Indian city of Hyderabad March 13, 2012.

Natco Pharma Ltd will soon launch a generic version of Celgene Corporation’s anti-cancer chemotherapy drug Vidaza in the US market.

It said this announcing receipt of final approval from US Food and Drug Administration for Abbreviated New Drug Application for Azacitidine for Injection (100mg per vial, single-dose vial), the generic version.

Natco and its marketing partner Breckenridge Pharmaceutical Inc plan to launch this product in the USA market in the near future, the Hyderabad-headquartered firm on Tuesday said.

A prescription anti-cancer chemotherapy drug, Vidaza is indicated to treat myelodysplastic syndrome (MDS). Vidaza generated total combined sales of $ 188 million during the 12-month period ended April 2017, the company said citing industry sales data.

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