FDA is pushing forward with its review of Mylan’s ANDA for generic Advair, according to the company, which is gaining confidence that the application could receive a first round approval. The experience for that application, which has a generic drug user fee, is a clear contrast to the firm's experience with its pre-GDUFA Copaxone filing.
Management at Mylan NVsaid FDA’s Office of Generic Drugs has offered a high-level of engagement when it comes to reviewing the company’s ANDA for a generic version of GlaxoSmithKline PLC’s blockbuster asthma drug Advair Diskus (fluticasone/salmeterol).
The progress is encouraging to Mylan, which is hopeful for a first round review, management said during Mylan’s second quarter...
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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