Cipla receives U.S. FDA approval for generic of asthma, COPD drug

Cipla has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in three strengths — 100/50 mcg, 250/50 mcg, and 500/50 mcg .

This approval represents Cipla’s first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network. The product is expected to be launched in the second quarter (Q2) of FY27 in the U.S., the company said on Monday.

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). Citing IQVIA numbers, Cipla said the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million.

“This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S,” CEO-Cipla North America Marc Falkin said.

MD and Global CEO Achin Gupta said the approval reinforces Cipla’s commitment to expanding access to complex therapies in the U.S. and highlights its strength in developing and scaling sophisticated inhalation products through integrated capabilities.”