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FDA approves Aurobindo’s azelastine hydrochloride nasal spray

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EAST WINDSOR, N.J. – Aurobindo Pharma  has gotten final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Application azelastine hydrochloride nasal spray 0.15% (205.5 mcg per spray). Aurobindo Pharma’s azelastine hydrochloride nasal spray 0.15% (205.5 mcg per spray) are an AB-rated generic equivalent to the reference listed drug (RLD), Astepro Nasal Spray, 0.15%, of Mylan Specialty.

Azelastine hydrochloride nasal spray is indicated for:

  • the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older.

Azelastine hydrochloride nasal spray has an estimated market size of US $15.2 Million for the twelve months ending September 2020 as per IQVIA.


ECRM_06-01-22


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