Glenmark wins FDA approvals for fluticasone nasal spray, rosuvastatin label update
The FDA approved two Glenmark Specialty applications, a new fluticasone propionate nasal spray and a labeling supplement for rosuvastatin calcium tablets.
Glenmark Specialty had two FDA actions clear this week, one new generic approval and one labeling update.
- The FDA approved Glenmark Specialty's original ANDA for fluticasone propionate nasal spray, a metered spray delivering 0.05 mg per spray, on August 18, 2026.1
- The FDA approved a labeling supplement, submission number 31, for Glenmark Specialty's rosuvastatin calcium tablets, covering strengths of 5 mg, 10 mg, 20 mg, and 40 mg base equivalent, on August 17, 2026.2
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