Aurobindo gets FDA approval for montelukast sodium oral granules

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application montelukast sodium oral granules USP, 4 mg. Montelukast sodium oral granules USP, 4 mg are an AB-rated generic equivalent to the reference listed drug, Merck Sharp & Dohme Corp.’s Singulair Oral Granules.

Montelukast sodium is a leukotriene receptor antagonist indicated for:

  • Prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
  • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older.

Montelukast sodium oral granules USP has an estimated market size of U.S. $6.9 Million for the twelve months ending December 2019 as per IQVIA.


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