According to Cipla, the FDA has approved the company’s ANDA for 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths of its generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of asthma and COPD. Cipla announced submission of an ANDA for the generic Advair Diskus in May 2020. The company notes that the approval is its first for a DPI that manufactured in the US.
Cipla Limited Managing Director and Global CEO Achin Gupta commented, “At Cipla, we’re passionate about respiratory care given our long-standing 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.”
Cipla North America CEO Marc Falkin said, “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”
Read the Cipla press release
