Glenmark Pharmaceuticals Secures U.S. FDA Approval for Fluticasone Propionate Nasal Spray

Glenmark Pharmaceuticals Secures U.S. FDA Approval for Fluticasone Propionate Nasal Spray

Glenmark Pharmaceuticals Secures U.S. FDA Approval for Fluticasone Propionate Nasal Spray​

Glenmark Pharmaceuticals Limited has received U.S. FDA approval for its Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray. The product is bioequivalent and therapeutically equivalent to the reference drug, Flonase® Nasal Spray, 0.05 mg/spray of Haleon US Holdings LLC [NDA 020121].

The approval positions Glenmark's spray for distribution in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIA® sales data for the 12-month period ending June 2026, the market for Flonase® Nasal Spray achieved annual sales of approximately $295.2 million.

The product details and market context are summarized below:

ProductGlenmark's Equivalent DrugReference DrugDosage
Fluticasone Propionate Nasal Spray USPBioequivalent and therapeutically equivalent toFlonase® Nasal Spray (Haleon US Holdings LLC)0.05 mg/spray

Marc Kikuchi, President & Business Head, North America at Glenmark Pharmaceuticals, commented on the approval, stating that it represents a further step in expanding their respiratory portfolio in the U.S. This development builds upon the strong foundation established by the company in this therapeutic area. He added that Glenmark remains committed to broadening access to quality and affordable treatment options tailored to address the evolving needs of patients and healthcare providers.

GLENMARK Stock Price Movement​

As of 9:17 AM, shares of GLENMARK PHARMACEUTICALS LIMITED are edging higher to ₹2264, climbing 0.78% in live trading. Limited activity so far today records a total traded volume of 177 shares for the pharmaceutical company.
 

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