Set-back for Hikma's generic Advair Diskus ANDA

Generic drugmaker Hikma Pharmaceuticals (LSE: HIK) has received a minor complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for its US generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder: VR315 [US]).

This is a copy of GlaxoSmithKline’s (LSE: GSK) top-selling asthma treatment that was developed in partnership with Vectura (LSE: VEC), a leading inhalation contract development and manufacturing organization (CDMO).

London-listed Hikma says it is working closely with the FDA to quickly address the small number of questions raised in the minor CRL. Once answered, Hikma can expect to receive a response from the FDA within 90 days. Both Hikma and Vectura are committed to bringing this important product to the US market and remain confident in the submission.