Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
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.
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.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
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.