 "Natco Pharma gains on tentative nod from USFDA for cancer drug")
Natco Pharma has moved higher by 9% to Rs 523 on the BSE after the company announced that its marketing partner, Mylan Inc., has received a tentative approval from USFDA for cancer drug Sorafenib, the generic version of Nexavar.
“Mylan Inc. has received a tentative approval for its abbreviated new drug application (ANDA) for Sorafenib tablets, 200mg, with the U.S. Food and Drug Administration (USFDA),” Natco Pharma said in a statement.
This product is the generic version of Nexavar, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Nacto Pharma and Mylan have filed an ANDA containing a paragraph IV certification for this product. The company manufactures this product at its facility in Kothur, Mahaboobnagar district, Telangana state, India, it added.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib tablets, 200mg, under brand name Nexaware, in the US market.
As per Bayer’s annual report, Nexavar had US sales of approximately $300 million for the 12 months ending December 31, 2015, the company said.
At 02:15 PM, the stock was up 6% at Rs 508 on the BSE as compared to a marginal 0.07% gain in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.27 million shares changed hands against an average sub 500,000 shares that were traded daily in past two weeks on the BSE and NSE.
“Mylan Inc. has received a tentative approval for its abbreviated new drug application (ANDA) for Sorafenib tablets, 200mg, with the U.S. Food and Drug Administration (USFDA),” Natco Pharma said in a statement.
This product is the generic version of Nexavar, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Nacto Pharma and Mylan have filed an ANDA containing a paragraph IV certification for this product. The company manufactures this product at its facility in Kothur, Mahaboobnagar district, Telangana state, India, it added.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib tablets, 200mg, under brand name Nexaware, in the US market.
As per Bayer’s annual report, Nexavar had US sales of approximately $300 million for the 12 months ending December 31, 2015, the company said.
At 02:15 PM, the stock was up 6% at Rs 508 on the BSE as compared to a marginal 0.07% gain in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.27 million shares changed hands against an average sub 500,000 shares that were traded daily in past two weeks on the BSE and NSE.