Wockhardt receives tentative US FDA approval for generic version of Patanol ophthalmic solution
01 July 2011
Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing 0.1 per cent solution of Olopatadine hydrochloride eye drops, used for allergic conjunctivitis.
Olopatadine is for the brand.
Patanol is marketed in the United States by Alcon Laboratories Inc., now a subsidiary of Novartis AG the brand's generic name Olopatadine.
The patent covering this product is under litigation in the US courts and Wockhardt will launch the product after its resolution.
Olopatadine is amongst the most widely used drugs in treating allergic conjunctivitis. Wockhardt is only one of three companies to receive a tentative approval for this product till date. According to IMS Health, the total market for this product in the US is about $230 million
''This is a major ANDA approval for Wockhardt in the ophthalmic segment'', said Wockhardt chairman Habil Khorakiwala. ''Sterile products including ophthalmic products continue to form an increasing and important part of our US product portfolio. It is this diverse streams of technically complex products that is helping Wockhardt keep up its rapid pace of growth in the US'', he remarked.
Wockhardt manufactures the ophthalmic preparations in the US FDA certified sterile formulation plant at Waluj, Aurangabad. Like most of its other seventy plus ANDA approvals, this product was also developed in-house.