GlaxoSmithKline PLC got only a fraction of its requests granted in FDA’s newly published draft guidance outlining recommendations for ANDA sponsors seeking to market copies of the company’s mega-seller Advair Diskus (fluticasone/salmeterol), leaving generic manufacturers with an easier path to approval than the company desired.
Advair Bioequivalence Guidance Falls Short of GSK’s Requests
FDA’s draft guidance requires clinical study but sets a lower bar to generics of GSK’s blockbuster asthma and COPD treatment than company proposed; standards appear poised for warm reception from generic challengers.