Aurobindo Pharma gets USFDA nod for its conjunctivitis drug
New Delhi: Drug firm Aurobindo Pharma has received approval from the US health regulator for generic Olopatadine Hydrochloride ophthalmic solution used for treatment of seasonal allergic conjunctivitis and is ready to launch the product in the American market.
"The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP in the strength of 0.1 per cent," Aurobindo Pharma said in a regulatory filing today.
The product is generic version of Alcon Laboratories Inc's Patanol ophthalmic solution/drops in the same strength, it added.
"The approved product has an estimated market size of USD 235 million for the 12 months ending October 2015, according to IMS," Aurobindo Pharma said.
The company currently has a total of 225 abbreviated new drug application (ANDA) approvals (197 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, it added.
"The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP in the strength of 0.1 per cent," Aurobindo Pharma said in a regulatory filing today.
The product is generic version of Alcon Laboratories Inc's Patanol ophthalmic solution/drops in the same strength, it added.
"The approved product has an estimated market size of USD 235 million for the 12 months ending October 2015, according to IMS," Aurobindo Pharma said.
The company currently has a total of 225 abbreviated new drug application (ANDA) approvals (197 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, it added.
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