Natco gets tentative nod to sell Sorafenib in US

The Dollar Business Bureau

Indian drug manufacturer Natco Pharma Ltd said on Friday that its marketing associate Mylan Inc has got tentative approval from the USFDA for marketing generic drug Sorafenib that is used in the treatment of cancer in the US market.

“Mylan Inc has got a tentative nod from the USFDA (United States Food and Drug Administration) for its Abbreviated New Drug Application (ANDA) for 200 mg Sorafenib tablets,” Natco Pharma said in a statement.

"Natco and Mylan have submitted an application comprising a Paragraph IV certification for Sorafenib tablets," it added. This product has been manufactured by Natco at its Kothur facility in the state of Telangana, the company said.

Sorafenib tablets in the strength of 200mg were sold by Onyx Pharmaceuticals Inc, Bayer Healthcare LLC and Bayer Healthcare Pharmaceuticals Inc, under the 'Nexavar' brand name in the US, it added.

"For the year ending December 31, 2015, around $300 million worth of Nexavar had been sold in the US market," Natco said. Sorafenib is the generic version of Nexavar and is used in the treatment of specific kinds of cancers such as unresectable hepatocellular carcinoma and advanced renal cell carcinoma", it added.

Incorporated in 1981 in Hyderabad, Natco Pharma Limited today has five manufacturing units spread across India with dedicated advanced R&D laboratories and capabilities in the development of new drugs