Sun Pharmaceutical Industries has received FDA approval for its abbreviated new drug application (ANDA) of Azelastine HCL nasal spray, 0.1% (137mcg/spray).
The generic equivalent to Medpointe Pharm's Astelin nasal spray is indicated to treat the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing and nasal pruritus.
The product is also used to treat symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults.
Azelastine HCL nasal spray has annual sales of around $144m in the US, the company said.
Sun Pharmaceutical Industries is a speciality pharmaceutical company which manufactures pharmaceutical formulations as branded generics as well as generics in India, US and other markets across the world.