Cipla Limited and its wholly owned subsidiary, Cipla USA Inc., have received approval from the US Food and Drug Administration (FDA) for the 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 approved product is therapeutically equivalent to Advair Diskus, a widely prescribed inhalation 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 valued at approximately US$908 million.

The approval marks a significant milestone for Cipla as it represents the company's first dry powder inhaler (DPI) approval from its US-based manufacturing network, highlighting its growing capabilities in developing and manufacturing complex respiratory products in the United States.

Achin Gupta, Managing Director & Global CEO, Cipla Limited, said, "At Cipla, we are 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 – North America, Cipla Limited, 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."

Supported by Cipla's vertically integrated inhalation platform, the approval further strengthens the company's US manufacturing footprint and reinforces its strategy of expanding access to complex respiratory therapies through advanced inhalation technologies.