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The FDA has given final approval to Aurobindo Pharma Limited to manufacture and market olopatadine hydrochloride ophthalmic solution, a generic equivalent of Alcon Laboratories Inc's Patanol drops.
The FDA has given final approval to Aurobindo Pharma Limited to manufacture and market olopatadine hydrochloride ophthalmic solution, a generic equivalent of Alcon Laboratories Inc’s Patanol drops.
The medication is used to treat signs and symptoms of seasonal allergic conjunctivitis.
Aurobindo stated in a press release that its ophthalmic solution was ready to launch.
Adverse effects from the solution include headache, blurred vision, dry eye, hyperemia, and hypersensitivity.
The product has not been tested in pediatric patients for safety and efficacy.
For the fiscal year ending in October 2015, the treatment had an estimated market size of $235 million, according to IMS Health.
Aurobindo currently has 225 abbreviated new drug approvals from the FDA.