Replies to post #209525 on Biotech Values

[DewDiligence]

MYL -3% on CRL for generic Advair:

http://finance.yahoo.com/news/mylan-comments-generic-advair-diskus-171600156.html

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.

Due to the difficulty in replicating GSK's inhalation device, there is not yet any FDA-approved generic for Advair, but TEVA has submitted a 505b2 NDA for a (non-substitutable) Advair knockoff.