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news.Sun Pharma has received FDA approval for an abbreviated new drug application (ANDA) to market a generic version of Optivar, azelastine ophthalmic solution, 0.05%.
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Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol, and glycerine.
Azelastine ophthalmic solution is used to treat itching of the eye caused by a condition known as allergic conjunctivitis. It works by preventing the effects of certain inflammatory substances, which are produced by cells in your eyes and sometimes cause allergic reactions.
Sun Pharma said that the drug usually starts to work within 3 minutes of placing the drops in the eye, and its effects usually last for about 8 hours.
Sun Pharma said that the sterile azelastine hydrochloride ophthalmic solution is therapeutically equivalent to Optivar Ophthalmic Solution, 0.05% from Medpointe Pharmaceuticals.
Optivar is a registered trademark of Meda Pharmaceuticals.