FDA grants final approval for McNeil Consumer Healthcare's generic Zyrtec to nine firms, the agency announces Dec. 27. Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan Pharmaceuticals, Par Pharmaceutical Companies, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt will offer the cetirizine HCl allergy and hives treatment in 5 mg and 10 mg tablets. FDA approved prescription-strength Zyrtec for over-the-counter sale Nov. 16, one week after approving McNeil's switch application for its Zyrtec-D allergy treatment decongestant combination product (1"The Tan Sheet" Nov. 12, 2007, p. 9). OTC Zyrtec is expected to be available for retail sale in late January...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
