Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to Lannett, which acquired US rights to the generic version of Advair Diskus in October 2019. Lannett said that the term of that deal has recently been extended to 12 years.
Lannett CEO Tim Crew commented, “The ANDA submission of generic Advair Diskus marks a significant advancement toward our goal of adding larger and more durable products to our portfolio. We anticipate a rigorous FDA review, extending beyond one review cycle, for the ANDA, given this is a complex combination drug/device product, involves two active pharmaceutical ingredients (APIs) and includes multiple dosage strengths. Currently, our agreements with Respirent include generic Advair Diskus, as well as second powder inhaler product, generic Flovent Diskus (fluticasone propionate powder inhaler). A key element of our growth strategy is to further build a franchise of respiratory drug/device products, and we are currently evaluating and in negotiation for additional product opportunities. We believe we have gained valuable experience during the development of the product and will learn important insights on the regulatory front, which we can bring to bear on these potential future opportunities.”
Crew added, “We continue to build an effective, close working relationship with our colleagues at Respirent – a team that has expertise and a deep working knowledge in developing, filing and manufacturing inhalation products and is committed to bringing affordable respiratory products to market.”
Read the Lannett press release.
