Cipla Ltd. has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder), as per the exchange filings.
The approval covers all three dosage strengths, with the product scheduled for launch in the United States during Q2 FY2026-27.
The approved medicine is a therapeutically equivalent version of Advair Diskus, a combination inhalation therapy used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The approval includes 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths.
The approval marks Cipla's first Dry Powder Inhaler (DPI) cleared from its U.S.-based manufacturing network.
It also represents the first dry powder inhaler approval from the company's New York manufacturing facility, strengthening its respiratory manufacturing capabilities in the country.
According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million.
The product is backed by Cipla's vertically integrated inhalation platform, supporting its manufacturing capabilities for complex respiratory treatments.
As per the exchange filings, Achin Gupta, Managing Director & Global CEO of Cipla, 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.”
Marc Falkin, Chief Executive Officer, Cipla North America, stated, “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”
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As of 28 July 2026, at 11:20 AM, Cipla Ltd share price was trading at ₹1,435.20 per share, reflecting a surge of 1.83% from the previous trading session.
The USFDA approval adds another respiratory product to Cipla's U.S. portfolio while marking an important manufacturing milestone for its New York facility. The approval spans all three strengths of Generic Advair Diskus and supports the company's respiratory business in the U.S. market.
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Published on: Jul 28, 2026, 12:30 PM IST
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