Dr Reddy's gets FDA approval for Roche drug generic; shares at record high

[November 07, 2014] MUMBAI (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd said on Friday it has received final approval from the U.S. Food and Drug Administration (FDA) to make a cheaper version of Roche Holding AG's antiviral Valcyte, sending its stock to a record high.

The move comes after Ranbaxy Laboratories Ltd said on Thursday that FDA had stripped the company of its tentative approval to launch the first copy of the drug due to quality control issues at its manufacturing plants.

"We confirm that launch is expected shortly," a spokeswoman for Dr Reddy's said a statement, without elaborating.

Ranbaxy, all of whose India-based manufacturing plants have been banned by the FDA from exporting to the United States, also lost its rights to a six-months market exclusivity for Valcyte generic on Thursday.
 

There are no companies with such sales exclusivity for Valcyte generic anymore, FDA spokeswoman Sandy Walsh said in a statement mailed to Reuters.

Valcyte had U.S. sales of 358 million Swiss francs ($368.50 million) in 2013, up 12 percent from a year earlier.

The FDA said it also granted U.S. firm Endo International Plc approval to launch Valcyte generic. Endo could not be reached for comment outside of U.S. business hours.

Dr Reddy's shares rose to their highest ever on Friday and clocked their biggest single-day percentage gain in more than a year. The stock ended up 4.5 percent at 3,397.15 rupees, while the main Mumbai market index fell 0.2 percent.

(1 US dollar = 0.9715 Swiss franc)

(Reporting by Zeba Siddiqui; Additional reporting by Indulal PM; Editing by Sumeet Chatterjee and Sunil Nair)

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