Share Prices & Company Research

Market News

15 Jan 2021 | 16:26

Hikma temporarily suspends launch of generic Advair Diskus

(Sharecast News) - Hikma Pharmaceuticals said on Friday that it had temporarily paused the launch of its generic version of GlaxoSmithKline's asthma treatment, Advair Diskus. The US Food and Drug Administration approved Hikma's Abbreviated New Drug Application (ANDA) for generic Advair Diskus in December 2020. However, the company has since submitted an amendment to the application, which reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application.

HIkma said the amendment will be classified as a Prior Approval Supplement and will not affect the approved status of the company's ANDA for generic Advair Diskus.

"Hikma will work closely with the FDA in its review and will commence distribution of the product once the review has been completed," it said.
Get in touch today
Join Redmayne Bentley
Talk to us now about opening a new account or transferring your account from another provider
0113 243 6941
Get in touch today
Contact your local office
Contact your local office to find out more
The value of your investments and the income from them may go down as well as up, and you could get back less than you invested.
Continuing our Personal Service: View our Latest COVID-19 Update: 1st March 2021
We use cookies on this site to improve your experience and help us provide you with a better website. An explanation of the cookies we use and their purpose can be found within our Cookie Policy. Your continued use of this site means you consent to the use of cookies.