USFDA23 Apr 2026, 09:49 am
Cipla USA Gets USFDA Nod for Albuterol Sulfate Inhalation
AI Summary
Cipla Ltd's wholly-owned subsidiary, Cipla USA Inc., has received final approval from the USFDA for its ANDA for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. This is the first AB-rated generic therapeutic equivalent of Ventolin® HFA, marketed by GlaxoSmithKline. The product, indicated for bronchospasm treatment and prevention, is expected to launch in the first half of FY 2026-27 in the USA. The total U.S. albuterol market is valued at approximately $1.5 billion.
Key Highlights
- Cipla USA receives USFDA approval for generic Albuterol Sulfate Inhalation Aerosol.
- The product is the first AB-rated generic equivalent to Ventolin® HFA.
- Launch is expected in H1 FY 2026-27 in the United States.
- The U.S. albuterol market is valued at approximately $1.5 billion.
- Approval enhances Cipla’s U.S. respiratory portfolio.