Sun Pharma's ANDA for Azelastine Nasal Spray Gets FDA Nod

Mumbai-based drug maker Sun Pharmaceuticals has revealed that its abbreviated new drug application for Azelastine HCL nasal spray has been approved by the US Food and Drug Administration for manufacturing in the strength of 0.1 per cent (137 mcg/spray).

The company said that Azelastine HCL is the generic version of Medpointe Pharm HLC's Astelin nasal spray and is used in treating symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing and nasal pruritus.

It added that the nasal spray has annual sales of $144 million in the United States and can also be used to treat rhinorrhea, nasal congestion and postnasal drip in adults.

Source: Medindia