Status update on ANDA for generic Advair Diskus (VR315 [US])

Published: 23-Sep-2020
Regulatory Drug Delivery Medical Devices

Vectura Group, an industry leading inhalation CDMO, confirms the announcement made by its partner Hikma Pharmaceuticals

Hikma 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 GlaxoSmithKline’s Advair Diskus (VR315 [US]).

Hikma 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.

Hikma has stated that it now expects to receive approval for its generic Advair Diskus in early 2021. Approval of VR315 (US) will trigger milestones to Vectura of $11 million, with a mid-teen percentage royalty on net sales of the product.

Aside from VR315 (US), all other Vectura guidance for 2020 remains unchanged.

  • Companies:
  • Vectura Group
  • Hikma Pharmaceuticals
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