Mylan comments on generic Advair Diskus abbreviated new drug application.
Mylan N.V. commented on the status of its abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) for its generic version of GlaxoSmithKline’s Advair Diskus.
In conjunction with Mylan’s GDUFA goal date, the company received a complete response letter from FDA regarding its ANDA for generic Advair Diskus. Mylan is in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA’s feedback with the agency.
Mylan, a global pharmaceutical company, markets a portfolio of approximately 7,500 products around the world, including antiretroviral therapies on which approximately 50 percent of people being treated for HIV/AIDS in the developing world depend. The products are marketed in more than 165 countries and territories.
(Source: PR Newswire)