Sun Pharma’s arm gets USFDA’s approval for generic Astelin Nasal Spray

Sun Pharmaceutical Industries’ subsidiary has been granted USFDA an approval for its Abbreviated New Drug Application (ANDA) for its generic version of Astelin, Azelastine HCL Nasal Spray, 0.1% (137 mcg/spray). This generic Azelastine HCL Nasal Spray, 0.1% (137 mcg/spray) is therapeutically equivalent to Astelin Nasal Spray from Medpointe Pharm HLC. Azelastine HCL nasal spray has annual sales of approximately $ 144 million in the US.

Azelastine HCL Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such asrhinorrhea, sneezing and nasal pruritus; and the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.

Sun Pharmaceutical Industries is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.