The US Food and Drug Administration (FDA) said it has granted final approval to Indian drugmaker Dr Reddy's Laboratories and US firm Endo International Plc to make cheaper copies of Roche Holding AG's antiviral Valcyte.
The US Food and Drug Administration (FDA) said it has granted final approval to Indian drugmaker Dr Reddy's Laboratories and US firm Endo International Plc to make cheaper copies of Roche Holding AG's anti-viral 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 US business hours.
Dr Reddys Labs stock price
On November 07, 2014, at 14:10 hrs Dr Reddys Laboratories was quoting at Rs 3409.00, up Rs 155.80, or 4.79 percent. The 52-week high of the share was Rs 3455.00 and the 52-week low was Rs 2250.00.
The company's trailing 12-month (TTM) EPS was at Rs 125.08 per share as per the quarter ended September 2014. The stock's price-to-earnings (P/E) ratio was 27.25. The latest book value of the company is Rs 547.59 per share. At current value, the price-to-book value of the company is 6.23.
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