The US Food and Drug Administration (FDA) has assigned Mylan a revised goal date for regulatory action on the firm’s generic Advair (fluticasone/salmeterol) dossier in mid-October. That date is three months after the company in mid-July this year responded to a complete response letter (CRL) that the FDA had sent towards the end of June, around the time of the 27 June previous target action date for Mylan’s application (Generics bulletin, 22 June 2018, page 1).
Stressing that the CRL had “only included labelling and chemistry, manufacturing and controls (CMC) comments”, Mylan’s president, Rajiv Malik, told...
