Cipla Scores First US Dry Powder Inhaler Approval

Cipla announced on Monday that it has secured approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA). This approval pertains to generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) and covers three specific strengths: 100/50 mcg, 250/50 mcg, and 500/50 mcg.

This approval is particularly noteworthy as it signifies Cipla's first dry powder inhaler (DPI) to receive clearance from its U.S.-based manufacturing facilities. The company plans to launch this product in the U.S. during the second quarter of fiscal year 2027. The generic Advair Diskus is recognized as a therapeutically equivalent alternative to the widely prescribed Advair Diskus, which is used for managing asthma and chronic obstructive pulmonary disease (COPD).

Executives highlighted the significance of this approval. Marc Falkin, CEO of Cipla North America, stated it represents their first dry powder inhaler from their New York facility, reflecting targeted investments in U.S. inhalation manufacturing capabilities. Achin Gupta, MD and Global CEO, emphasized that this achievement reinforces Cipla's dedication to broadening access to complex therapies within the U.S. market and showcases their integrated strengths in developing and scaling sophisticated inhalation products.