New Delhi: Drug maker Wockhardt on Friday said it has received tentative approval from the US health regulator to market Olopatadine hydrochloride eye drops in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) to market 0.1% solution of Olopatadine hydrochloride eye drops, used in treating allergic conjunctivitis, Wockhardt said in a statement.
“This is a major approval for Wockhardt in opthalmic segment,” Wockhardt Chairman Habil Khorakiwala said, adding that sterile products, including opthalmic products, continue to form an important part of the company’s US product portfolio.
Olopatadine hydrochloride eye drops are the generic equivalent of Alcon Laboratories Inc’s Patanol brand.
“The patent covering this product is under litigation in the US courts and Wockhardt will launch the product after resolution of the same,” the company said.
According to IMS Health data, the total market for Olopatadine in the US is nearly $230 million.
“Wockhardt is only one of the three companies to receive a tentative approval for this product till date,” it said, adding that the firm produces the product in its USFDA certified plant at Waluj in Aurangabad.
Shares of Wockhardt were today trading at Rs 369.55 on the Bombay Stock Exchange in the late afternoon trade, up 0.79% from previous close.