Mumbai, India: Cipla has received approval from the U.S. Food and Drug Administration (FDA) for its generic version of Advair Diskus, covering all three strengths of the inhaled medicine used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Cipla Limited and its wholly owned subsidiary Cipla USA Inc. announced the approval for fluticasone propionate and salmeterol inhalation powder in strengths of 100/50 mcg, 250/50 mcg and 500/50 mcg. The product is therapeutically equivalent to Advair Diskus, a combination treatment prescribed for respiratory conditions.
The approval also marks a manufacturing milestone for the company. Cipla said the product is its first dry powder inhaler (DPI) approved by the U.S. FDA from its U.S.-based manufacturing network. The company said the development strengthens its capabilities in producing complex inhalation medicines within the United States.
According to IQVIA data cited by Cipla, the U.S. market for fluticasone propionate and salmeterol inhalation powder was valued at approximately $908 million. The approval therefore gives Cipla access to a significant segment of the U.S. respiratory medicines market.
The product has been developed through Cipla’s vertically integrated inhalation platform. The company said the approval forms part of its efforts to expand manufacturing capabilities for complex respiratory treatments in the U.S.
Cipla North America CEO Marc Falkin said the approval follows investments in differentiated inhalation manufacturing capabilities at the company’s facility in New York. Managing Director and Global CEO Achin Gupta said the development would support the company’s efforts to expand access to complex respiratory therapies in the U.S.
Cipla, established in 1935, operates 46 manufacturing sites globally and supplies products across more than 70 markets. The company has a portfolio spanning respiratory medicines along with therapies in areas including antiretroviral treatment, urology, cardiology, anti-infectives and central nervous system disorders.
The latest FDA approval adds another complex inhalation product to Cipla’s U.S. portfolio while expanding the role of its American manufacturing operations in respiratory drug production.
Source: This article is based on an official press release issued by Cipla
Cipla-Receives-U-S-FDA-Approval-for-Generic-Advair-Diskus.pdf
