Cipla Limited and its wholly owned subsidiary, Cipla USA Inc., have received approval from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for Generic Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) across all three dosage strengths: 100/50 mcg, 250/50 mcg, and 500/50 mcg.
The product serves as a therapeutically equivalent version of Advair Diskus®, a widely prescribed combination treatment indicated for asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million. This milestone represents Cipla’sfirst dry powder inhaler (DPI) approval manufactured at its New York facility, marking a key expansion of its complex respiratory infrastructure in North America.
“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,” said Achin Gupta, Managing Director & Global CEO of Cipla Limited.
Marc Falkin, Chief Executive Officer of Cipla North America, added that targeted investments in building differentiated inhalation capabilities at the New York site will strengthen the company’s ability to ensure a reliable, high-quality supply in a key competitive market.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
