Cipla Gets USFDA Approval for Generic Advair Diskus

Cipla Ltd announced it has received approval from the United States Food and Drug Administration (USFDA) 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. This product is a therapeutically equivalent version of Advair Diskus®, used for asthma and COPD. The US market for this product is valued at approximately $908 million. This approval marks Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network. The product is expected to launch in the United States in Q2 of FY 2026-27.