Cipla receives U.S. FDA approval for generic of asthma, COPD drug
Cipla has received U.S. FDA approval 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 is the first dry powder inhaler (DPI) approval from Cipla's U.S.-based manufacturing network, specifically its New York facility. The product, a therapeutically equivalent version of Advair Diskus used for asthma and chronic obstructive pulmonary disease (COPD), is expected to launch in the second quarter of FY27 in the U.S. According to IQVIA data, the U.S. market for this drug is approximately $908 million. Cipla executives highlighted the approval as a milestone in expanding access to complex therapies and demonstrating the company's inhalation manufacturing capabilities.
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