USFDA Approves Cipla's Generic Advair Diskus for Asthma, COPD
New Delhi: Cipla Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three strengths-100/50 mcg, 250/50 mcg and 500/50 mcg.
The approved product is therapeutically equivalent to Advair Diskus, a combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million.
The approval marks Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, representing a significant milestone in the company's efforts to expand its complex respiratory portfolio and manufacturing capabilities in the United States.
Commenting on the approval, Achin Gupta, Managing Director and Global CEO, Cipla Limited, said, "At Cipla, we're passionate about respiratory care given our longstanding expertise. This approval reinforces our commitment to expanding access to complex therapies in the U.S. and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities."
The company said the product is backed by its vertically integrated inhalation platform and reflects its continued investment in strengthening U.S. manufacturing capabilities for complex respiratory therapies.
Marc Falkin, Chief Executive Officer, Cipla North America, added, "This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category."
Established in 1935, Cipla is a global pharmaceutical company focused on complex generics and specialty medicines across India, South Africa, North America and other regulated and emerging markets. The company operates 46 manufacturing facilities producing more than 50 dosage forms and 1,500 products for over 70 markets worldwide. Its key therapeutic areas include respiratory care, antiretrovirals, urology, cardiology, anti-infectives and central nervous system disorders.
