The approval was granted for the company’s Abbreviated New Drug Application (ANDA) covering all three strengths of the product — 100/50 mcg, 250/50 mcg and 500/50 mcg.
“Cipla Limited today announced that Cipla Limited has received U.S. Food and Drug Administration (FDA) approval 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,” according to a stock exchange filing.
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Cipla said the product is a therapeutically equivalent version of Advair Diskus, a combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The company said the product is expected to be launched in the United States in the second quarter of financial year 2026-27.
According to IQVIA, the US market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million. This approval represents Cipla’s first dry powder inhaler (DPI) approval from its US-based manufacturing network, marking a significant milestone in the company’s continued expansion of complex respiratory capabilities in the United States.
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.”
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Backed by Cipla’s vertically integrated inhalation platform, the product reflects the company’s commitment to strengthening US manufacturing capabilities for complex respiratory treatments.
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 US. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category.”
Shares of Cipla Ltd ended at ₹1,416.00, down by ₹5.10, or 0.36%, on the BSE.
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