FDA approves change in Claritin labeling
KENILWORTH, N.J. Schering-Plough on Tuesday announced that the Food and Drug Administration approved additional labeling for Claritin that emphasizes the allergy medicine is appropriate for use to help treat both indoor (perennial) and outdoor (seasonal) allergies.
“Schering-Plough is pleased that the FDA has approved the change to the Claritin label to help us to communicate to consumers that Claritin works hard to relieve both indoor and outdoor allergies,” stated John O’Mullane, vice president of research and development for Schering-Plough Consumer Health Care.
Congressmen request BTC information from GAO
WASHINGTON House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., have requested an update of the General Accounting Office’s 1995 evaluation on the potential benefits and pitfalls associated with a third-class of drugs in a letter to GAO Comptroller General David Walker, FDANews reported Tuesday.
The FDA held a meeting in October to help identify the issues and hurdles that would need to be addressed if a behind-the-counter class of drugs were to be considered. The FDA has established no timetable for a next step, such as a call for public comments and/or an advisory committee hearing, following that meeting.
The 1995 GAO report on BTC drugs concluded there were no major benefits associated with a third class.
Virulite seeks suitor, FDA approval for new cold sore remedy
COSTA MESA, Calif. Virulite, a medical device manufacturer developing a new treatment for cold sores, is looking for a U.S. suitor, having retained Compass Point Capital and Murphy Business and Financial Corporation as its mergers and acquisitions advisors, the U.K. company announced Friday.
Virulite is presently in the process of obtaining Food and Drug Administration clearance for a portable, hand held device that uses an invisible, non-thermal band of near-infrared light that, according to the company, reduces the healing time of cold cores by up to one half.
The company completed a U.S. market test of the product through Walgreens’ online distribution channel, where Virulite outsold all competing cold sore remedies, including the current market leader, the topical cream Abreva by GlaxoSmithKline, Virulite reported.