Glenmark secures USFDA nod for OTC Nasal Spray; launches Generic Milnacipran tablets in US
The product has been deemed bioequivalent to Flonase Allergy Relief Nasal Spray, marketed by Haleon US Holding LLC. The approved spray will be distributed in the US by Glenmark Therapeutics Inc., USA.
According to Nielsen syndicated data for the 52-week period ended March 3, 2026, the Flonase Allergy Relief Nasal Spray market recorded annual sales of approximately $384.7 million, indicating a sizeable opportunity for Glenmark in the OTC segment.
Marc Kikuchi, President & Business Head, North America, said, ?We are excited to announce the recent approval of Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC). As the first approved nasal spray distributed by Glenmark Therapeutics Inc., USA in the OTC space, we look forward to bringing this quality over-thecounter solution to our customers when we launch in April 2026.?
Separately, Glenmark Pharmaceuticals Inc., USA also announced the launch of Milnacipran Hydrochloride Tablets in strengths of 12.5 mg, 25 mg, 50 mg, and 100 mg. The product is the authorized generic version of Savella Tablets.
As per IQVIA sales data for the 12-month period ending January 2026, the Savella tablets market generated annual sales of around $102.9 million.
Marc Kikuchi, President & Business Head, North America said, ?We are excited to announce the launch of Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg, the authorized generic to Savella? Tablets. This launch further strengthens our commitment to bring to market quality and affordable alternatives for patients.?
The dual developments underline Glenmark?s strategic push to strengthen its presence across both OTC and prescription segments in North America.
Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.
Glenmark Pharmaceuticals reported a 15.9% jump in consolidated net profit to Rs 403.21 crore on a 17.8% increase in revenue from operations to Rs 3,888 crore in Q3 FY26 over Q3 FY25.
Shares of Glenmark Pharmaceuticals declined 2.03% to Rs 2,142.10 on the BSE.
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