Cipla Receives FDA Approval For Generic Advair Diskus In All Strengths
(RTTNews) - Cipla Limited (CIPLA) announced that the U.S. FDA has approved its Abbreviated New Drug Application (ANDA) for the generic version of Advair across all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg.
Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is a widely prescribed combination therapy for asthma and chronic obstructive pulmonary disease (COPD). Cipla's product is a therapeutically equivalent version, offering patients a lower-cost alternative in a U.S. market estimated at $908 million, according to IQVIA.
This approval marks Cipla's first dry powder inhaler (DPI) approval from its U.S. manufacturing network, representing a significant milestone in the company's expansion of complex respiratory capabilities in the United States.
Achin Gupta, Managing Director & Global CEO, Cipla, said the approval reinforces the company's commitment to expanding access to complex therapies in the U.S. and highlights its strength in scaling sophisticated inhalation products through integrated capabilities.
Marc Falkin, Chief Executive Officer, of Cipla North America added, that the approval reflects targeted investments in differentiated inhalation manufacturing and strengthens Cipla's ability to provide reliable, high-quality supply in a competitive category.
This FDA approval underscores Cipla's growing presence in the U.S. generics market and its long-standing expertise in respiratory care.
CIPLA has traded between INR 1,165.70 and INR 1,673.00 over the past year. The stock closed Tuesday's trading at INR 1,444.60, up 2.50%.
