02:00 Tue 22 Sep 2020
Hikma Pharmaceutical - Hikma updates on ANDA for generic Advair Diskus®

Hikma is working closely with the FDA to quickly address the small number of questions raised in the CRL. Once answered, Hikma can expect to receive a response from the FDA within 90 days. Hikma now expects to receive approval for its generic Advair Diskus® in early 2021. As a result, Generics revenue is now anticipated to be in the range of
Hikma and its partner Vectura Group, are committed to bringing this important product to the US market and remain confident in the submission.
1 Advair® and Advair Diskus® are registered trademarks of Glaxo Group Limited.
- ENDS -
Enquiries
Hikma Pharmaceuticals PLC
EVP, Strategic Planning and Global Affairs | +44 (0)20 7399 2760/ +44 7776 477050
|
US Communications and Public Affairs | +1 732 720 2830/ +1 732 788 8279 +1 732 720 2814/+1 848 254 4875 |
Teneo (Press):
Charles Armitstead / Camilla Cunningham +44 (0)7703 330 269/ +44 (0)7464 982 426
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BBB-/stable S&P)
Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
Quick facts: Hikma Pharmaceuticals PLC
Price: -
Market: AIM
Market Cap: -
Follow
NO INVESTMENT ADVICE
The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...
FOR OUR FULL DISCLAIMER CLICK HERE