Cipla receives U.S. FDA approval for generic of asthma, COPD drug
Cipla has received U.S. FDA approval for a generic version of the asthma and COPD medication Advair Diskus. The company plans to launch the product in the U.S. market by the second quarter of fiscal year 2027.
Why it matters
This approval represents a significant expansion of Cipla's manufacturing capabilities in the U.S. and increases competition in the respiratory therapy market.
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.
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