Drugmaker Cipla Ltd has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for the generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all three dosage strengths.
The approval covers 100/50 mcg, 250/50 mcg and 500/50 mcg strengths. The product is therapeutically equivalent to Advair Diskus, a widely prescribed combination therapy used 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 $908 million.
Manufacturing milestone
Cipla said the approval marks the first dry powder inhaler (DPI) approval from its US-based manufacturing network, representing a key milestone in the company’s strategy to expand its complex respiratory product portfolio in the United States.
The company said the product has been developed using its vertically integrated inhalation platform, reinforcing its focus on strengthening US manufacturing capabilities for complex respiratory therapies.
Expanding access to respiratory therapies
Cipla Ltd Managing Director and Global CEO Achin Gupta said the approval underscores the company’s long-standing expertise in respiratory care.
“At Cipla, we’re passionate about respiratory care given our longstanding expertise. This approval reinforces our commitment to expanding access to complex therapies in the US and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities,” he said.
Boost for US operations
Cipla North America Chief Executive Officer Marc Falkin said the approval is an important milestone for the company’s US manufacturing operations.
“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 US. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category,” he said.
The approval further strengthens Cipla’s presence in the US respiratory market, a key focus area for the company, while enhancing its portfolio of complex generic inhalation products.