- Cipla 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 U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million, according to IQVIA.
- 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.
- Cipla's CEO, Achin Gupta, stated that the approval reinforces the company's commitment to expanding access to complex therapies in the U.S.
- Marc Falkin, CEO of Cipla North America, emphasized that this approval highlights the company's strength in developing and scaling sophisticated inhalation products.
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.12
According to IQVIA, the U.S. market for this inhalation powder is valued at approximately $908 million. The approval signifies Cipla's first dry powder inhaler from its U.S.-based manufacturing network, with plans to launch the product in the second quarter (Q2) of FY27.34567
CEO-Cipla North America Marc Falkin 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.”9
MD and Global CEO Achin Gupta emphasized that 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.8
This strategic move is expected to enhance Cipla's presence in the competitive U.S. market for respiratory therapies, further solidifying its role in providing essential medications.
“Cipla's approval for the generic Advair Diskus marks its first dry powder inhaler from its New York facility, reflecting significant investments in inhalation manufacturing capabilities. The product is expected to launch in the U.S. in the second quarter of FY27, expanding access to complex therapies.”
Medical Dialogues
