Amneal secures three mometasone furoate labeling supplement approvals in one week

This week's Amneal items center on a batch of FDA labeling approvals for mometasone furoate, with a bosentan approval and an ongoing Phase 3 trial also on record.

• Amneal Pharms received FDA approval for three separate labeling supplements covering its mometasone furoate nasal spray (ANDA207989), submission number 15, approved with a status date of 2026-10-30¹, submission number 11, approved with the same status date², and submission number 3, also approved with a status date of 2026-10-30³.
• Amneal Pharms Co previously received FDA approval for a supplement submission under the REMS submission class for its bosentan tablets (ANDA209742), covering both 125 mg and 62.5 mg strengths, with submission number 17 approved and a status date of 2026-10-27⁴.
• Amneal is running a Phase 3, single-arm study of a subcutaneous testosterone cypionate auto-injector in adult males with hypogonadism, evaluated through Week 24. The trial (NCT07898072) is recruiting, with an actual start date of September 28, 2026, and was first posted October 27, 2026.⁵ Enrollment is estimated at 190 participants.⁵ Treatment begins at a 75 mg weekly dose, with later adjustments to 50 mg or 100 mg depending on testosterone levels measured during the study.⁵ Estimated primary completion is March 31, 2027.⁵