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Sun Pharma gets US FDA tentative nod for generic Optivar |
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Friday, 03 July 2009 |
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 Sun Pharmaceutical Industries Ltd announced the receipt of a tentative approval from US FDA for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Optivar, azelastine ophthalmic solution, 0.05%.
This sterile azelastine hydrochloride ophthalmic solution is therapeutically equivalent to Optivar ophthalmic solution, 0.05 per cent from MedPointe Pharmaceuticals which has annual sales of approximately USD 48 million in the US. Azelastine is a selective antihistamine for the treatment of the itching of the eyes associated with allergic conjunctivitis. Optivar is a registered trademark of MedPointe Pharmaceuticals. |
