Aurobindo Pharma receives USFDA nod for anti-allergic drugs
According to IMS, the approved product has an estimated market size of $235 million for the twelve months ending October 2015Aurobindo Pharma Ltd. on Tuesday announced that it has received US Food & Drug Administration (USFDA) approval to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% - a solution used for the treatment of allergic conjunctivitis. “This product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Patanol Ophthalmic Solution/Drops, 0.1%, of Alcon Laboratories,” Aurobindo Pharma Ltd. said in a statement. According to IMS, the approved product has an estimated market size of $235 million for the twelve months ending October 2015. This is the 20th ANDA (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 225 ANDA approvals, which consist of 197 final approvals and 28 tentative approvals from USFDA as well as 10 from Aurolife Pharma LLC. Hyderabad – headquartered Aurobindo Pharma Ltd. manufactures generic pharmaceuticals and active pharmaceutical ingredients across 6 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterological and anti-allergies. The company’s manufacturing facilities have received approvals from several leading regulatory agencies including USFDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa and ANVISA Brazil.
December 23, 2015 |11:30pm IST
to success.