CIPLA USA INC.

Cipla Secures FDA Approval for First U.S.-Manufactured Generic Advair Diskus Across All Three Strengths

- Cipla Limited received U.S. FDA approval for its 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 approval represents Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, specifically its New York facility. - The U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million, according to IQVIA data. - The generic is a therapeutically equivalent version of Advair Diskus, indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).