Sun Pharmaceutical Industries today said it has received approval from the US health regulator to sell its generic version of Astelin, used in treating nasal allergies, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for its generic Azelastine HCL nasal spray, which is therapeutically equivalent to Medpointe Pharm HLC's Astelin nasal spray, Sun Pharma said in a statement.
Sun Pharma has received approval for its product in the strength of 0.1% (137 mcg/spray), it added.
According to the company estimates, Azelastine HCL nasal spray has annual sales of around $144 million in the US.
The drug is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing and nasal pruritus.
It is also used for treating symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults.
Shares of Sun Pharma were trading at Rs 565.10 on the BSE in afternoon trade, down 1.09% from its previous close.