1 week ago
Glenmark Gets US Approval for Generic Fluticasone Nasal Spray
Glenmark received permission to sell a generic nasal spray in the United States.
The medicine is called fluticasone propionate.
It is used to treat rhinitis, including allergic rhinitis.
Each spray contains 0.05 milligrams of the medicine.
The US Food and Drug Administration approved the product.
Glenmark says the spray works like the brand-name Flonase spray.
A Glenmark company in the United States will distribute it.
The company said the approval supports its respiratory-medicine business.
Flonase had reported sales of about USD 295.2 million during the stated 12-month period.
The US Food and Drug Administration approved Glenmark’s generic fluticasone propionate nasal spray.
The spray has a strength of 0.05 mg per spray and is indicated for rhinitis.
Glenmark said its product is bioequivalent and therapeutically equivalent to Flonase nasal spray.
Glenmark Pharmaceuticals Inc., USA, will distribute the product in the United States.
Flonase nasal spray recorded approximately USD 295.2 million in sales in the 12 months ended June 2026, according to cited IQVIA data.
- Who
- Glenmark Pharmaceuticals Ltd received approval from the US Food and Drug Administration, with distribution by Glenmark Pharmaceuticals Inc., USA.
- What
- Approval was granted for a generic fluticasone propionate nasal spray containing 0.05 mg per spray.
- Where
- The product will be distributed in the United States.
- When
- The approval was announced on Thursday; the cited sales period ended in June 2026.
- Why
- Glenmark said the approval expands its US respiratory portfolio and builds on its position in the therapeutic area.
Key facts
- Regulator
- US Food and Drug Administration
- Product
- Generic fluticasone propionate nasal spray
- Strength
- 0.05 mg per spray
- Indication
- Rhinitis, including allergic rhinitis
- Reference drug
- Flonase nasal spray, 0.05 mg per spray
- US distributor
- Glenmark Pharmaceuticals Inc., USA
- Reported Flonase sales
- Approximately USD 295.2 million for the 12 months ended June 2026, according to cited IQVIA data
Quotes
Marc Kikuchi
President and Business Head, North America, Glenmark Pharmaceuticals
“it marks another step in expanding the company's respiratory portfolio in the US and builds on the strong foundation it has established in this therapeutic area.”
NDTV
Sources
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