Hikma resumes launch of generic Advair Diskus in USA
London-listed Hikma Pharmaceuticals (LSE: HIK) says it has resumed the launch of its generic version of GlaxoSmithKline’s (LSE: GSK) Advair Diskus in the USA, following US Food and Drug Administration approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021.
The news saw Hikma’s shares gain more than 3% to 2,451 pence by mid-afternoon trading today. The company has developed the copy of GSK’s top-selling asthma treatment in partnership with Vectura (LSE: VEC), a leading inhalation contract development and manufacturing organization (CDMO), whose shares were also up more than 3% at 115.30 pence.
The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its abbreviated new drug application (ANDA).
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze