This authorization serves as a milestone for the Mumbai-based pharmaceutical firm, marking its first dry powder inhaler approval derived from its U.S.-based manufacturing network. The medication is used to treat asthma and chronic obstructive pulmonary disease, providing a therapeutically equivalent alternative to the established brand-name therapy.
Cipla Wins FDA Approval for Generic Advair Diskus Inhalers
The U.S. Food and Drug Administration has cleared Cipla Limited to market a generic version of the respiratory medication Advair Diskus. The approval covers all three dosage strengths of the fluticasone propionate and salmeterol powder, targeting a U.S. market segment valued at approximately $908 million annually.
Achin Gupta, Managing Director and Global CEO of Cipla, noted that the approval underscores the company’s ability to develop and scale sophisticated inhalation products. The production will be handled by the company’s New York facility, a move that Marc Falkin, CEO of Cipla North America, describes as a result of targeted investments in domestic manufacturing capabilities. By utilizing its vertically integrated platform, the company intends to secure a reliable supply chain within this highly competitive respiratory care category.
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