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FinanceCipla gets U.S. FDA approval for generic Advair Diskus for asthma, COPD
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Cipla has received U.S. FDA approval for its abbreviated new drug application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in three strengths: 100/50 mcg, 250/50 mcg, and 500/50 mcg. This is the first dry powder inhaler (DPI) approval from Cipla's U.S.-based manufacturing network, specifically its New York facility. The product, a therapeutically equivalent version of Advair Diskus used for asthma and chronic obstructive pulmonary disease (COPD), is expected to launch in the second quarter of FY27 in the U.S. According to IQVIA data, the U.S. market for this drug is approximately $908 million. Cipla executives highlighted the approval as a milestone in expanding access to complex therapies and demonstrating the company's inhalation manufacturing capabilities.
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This is the first dry powder inhaler (DPI) approval from Cipla’s U.S.-based manufacturing network. The product is expected to be launched in the second quarter (Q2) of FY27 in the U.S.
Published – July 28, 2026 09:06 pm IST | HYDERABAD
By The Hindu Bureau
Cipla has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in three strengths:
- 100/50 mcg
- 250/50 mcg
- 500/50 mcg
This approval represents Cipla’s first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network. The product is expected to be launched in the second quarter (Q2) of FY27 in the U.S., the company said on Monday.
The product is a therapeutically equivalent version of Advair Diskus, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Citing IQVIA data, Cipla stated that the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million.
“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.,” said Marc Falkin, CEO of Cipla North America.
MD and Global CEO Achin Gupta said the approval reinforces Cipla’s commitment to expanding access to complex therapies in the U.S. and highlights its strength in developing and scaling sophisticated inhalation products through integrated capabilities.
Published – July 28, 2026 09:06 pm IST
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Cipla receives U.S. FDA approval for generic of asthma, COPD drug