HOME > MARKETS > COMPANY NEWS
  COMPANY NEWS
COMPANY
Cipla gets USFDA’s approval for Generic Advair Diskus
Jul-28-2026

Cipla has received U.S. Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three strengths-100/50 mcg, 250/50 mcg, and 500/50 mcg.

The product is a therapeutically equivalent version of Advair Diskus, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is around $908 million. This approval represents Cipla’s first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, marking a significant step in the company’s continued expansion of complex respiratory capabilities in the United States.

Backed by Cipla’s vertically integrated inhalation platform, the product reflects the company’s commitment to strengthening U.S. manufacturing capabilities for complex respiratory treatments.

Cipla is in the business of manufacturing, developing, and marketing wide range of branded and generic formulations and Active Pharmaceutical Ingredients (APIs).

  RELATED NEWS >>