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Mumbai: The US Food and Drug Administration (FDA) said it has granted final approval to Indian drugmaker Dr Reddy’s Laboratories Ltd and US firm Endo International Plc to make cheaper copies of Roche Holding AG’s antiviral Valcyte.
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.
Ranbaxy, whose all 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 exlusivity for Valcyte generic.
There are no companies with such sales exclusivity for Valcyte generic anymore, FDA spokeswoman Sandy Walsh said in a statement mailed to Reuters.
A spokeswoman for Dr Reddy’s did not immediately respond to a request for comment on Friday. Endo could not be reached outside the U.S. business hours.
Reuters
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