Teva completes Phase 3 asthma inhaler trial; registers vitiligo program and five ANDA actions

Teva Branded Pharmaceutical Products R&D LLC closed out a Phase 3 asthma trial and logged a cluster of new study registrations and FDA generic approvals this week.

• A Phase 3 trial of fluticasone propionate/albuterol sulfate combination delivered by a multidose dry powder inhaler with electronic module, in participants 12 and older with asthma, reached completed status. The randomized, parallel-group study enrolled 649 participants and compared the combination against fluticasone alone, albuterol alone, and placebo.¹ The primary completion and study completion dates were both October 26, 2026.
• The FDA approved an original ANDA for fluticasone propionate metered aerosol inhalers. The approval, sponsored by Teva Pharms USA Inc, covers 0.11 mg and 0.22 mg per inhalation strengths and was recorded with a submission status date of November 3, 2026.²
• Sanofi registered a Phase 1 drug-drug interaction study of duvakitug, also known as SAR447189, with Teva Branded Pharmaceutical Products R&D LLC as a collaborator. The open-label, single-sequence study will examine the effects of duvakitug on the pharmacokinetics of selected cytochrome P450 substrates in adults with moderately to severely active ulcerative colitis or Crohn's disease.³ Approximately 25 participants are planned³, with an estimated start of November 3, 2026.
• Teva registered a combined Phase 2b/Phase 3 program of TEV-53408 for non-segmental vitiligo, not yet recruiting. The trials aim to learn whether TEV-53408 can help bring color back to facial and body skin in adults with non-segmental vitiligo compared with placebo.⁴ Participants will receive TEV-53408 or placebo by subcutaneous injection⁴, with 1020 participants estimated and an estimated start of November 16, 2026.
• Teva registered an observational study of subcutaneous long-acting injectable olanzapine (TV-44749), called RADIANCE, in adults with schizophrenia, not yet recruiting. The study's main purpose is to evaluate how TV-44749 works in routine clinical practice for adults with schizophrenia⁵, with 1085 participants estimated and an estimated start of March 30, 2027.
• The FDA approved a labeling supplement for clonidine hydrochloride extended-release tablets. The supplement, sponsored by Actavis Elizabeth, covers 0.1 mg and 0.2 mg strengths and carries a submission status date of November 3, 2026.⁶
• The FDA approved a labeling supplement for isotretinoin capsules. The supplement, sponsored by Actavis Labs FL, covers capsule strengths from 10 mg to 40 mg and was recorded with a submission status date of November 3, 2026.⁷
• The FDA approved an original ANDA for carbidopa and levodopa extended-release capsules. The approval, sponsored by Actavis Labs FL, covers four combination strengths and carries a submission status date of November 2, 2026.⁸