Cipla Limited, along with its wholly owned subsidiary Cipla USA Inc., announced on July 27, 2026, that it has received approval from the United States Food and Drug Administration (FDA) 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.
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).
According to IQVIA, the US market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million, underscoring the commercial significance of this regulatory clearance.
Leadership CommentaryCommenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, said: "At Cipla, we're passionate about respiratory care given our long-standing 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."
Cipla Limited, along with its wholly owned subsidiary Cipla USA Inc., announced on July 27, 2026, that it has received approval from the United States Food and Drug Administration (FDA) 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. 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).
Key Details of the Approval
The following table summarises the key parameters of this regulatory approval:
Parameter: Details Product: Generic Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) Strengths Approved: 100/50 mcg, 250/50 mcg, and 500/50 mcg Regulatory Body: US Food and Drug Administration (FDA) Application Type: Abbreviated New Drug Application (ANDA) Indication: Asthma and Chronic Obstructive Pulmonary Disease (COPD) US Market Size (IQVIA): Approximately $908 million Manufacturing Origin: US-based manufacturing network (New York facility) Expected US Launch: Q2 of FY 2026-27
A Milestone in Cipla's US Respiratory Portfolio
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 expansion of complex respiratory capabilities in the United States. According to IQVIA, the US market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million, underscoring the commercial significance of this regulatory clearance. The product is backed by Cipla's vertically integrated inhalation platform and reflects the company's commitment to strengthening US manufacturing capabilities for complex respiratory treatments.
Leadership Commentary
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, said: "At Cipla, we're passionate about respiratory care given our long-standing 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, 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."
About Cipla Limited
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. Key highlights of the company's global presence include:
46 manufacturing sites around the world producing 50+ dosage forms and 1,500+ products
around the world producing 50+ dosage forms and 1,500+ products Ranked 3rd largest in pharma in India (IQVIA MAT Jun'26)
(IQVIA MAT Jun'26) 2nd largest in the pharma prescription market in South Africa (IQVIA MAT May'26)
(IQVIA MAT May'26) 2nd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Jun'26)
(Repulses + MDI) products (IQVIA MAT Jun'26) Strengths in respiratory, antiretroviral, urology, cardiology, anti-infective, and CNS segments
Cipla's product is expected to be launched in Q2 of FY 2026-27 in the United States, further strengthening its presence in the competitive US generics market.
