BURROUGHS WELLCOME's NIX WINS THREE-YEAR EXCLUSIVITY FOR OTC PEDICULICIDE CREAM RINSE until May 1993 for one indication -- use on children between the ages of two months and two years. FDA Center for Drug Evaluation and Research Director Carl Peck, MD, explained the exclusivity grant in a March 23 letter responding to a Dec. 9, 1990 petition from the company. FDA approved the Rx-to-OTC switch for Nix (permethrin) on May 2, 1990. Burroughs Wellcome subsequently repeated its request for full exclusivity for the lice-killing cream rinse, arguing that the Office of Generic Drugs did not fully apprehend "the role that new clinical information played in the approval process." According to the petition, Burroughs Wellcome "submitted data from five studies that it sponsored and conducted." The company claims that the studies, which provided "extensive" safety information, were "essential to FDA approval for OTC marketing of Nix" and therefore the company merited extended exclusivity for the product. In his response, Peck points to one study involving 1,701 patients that "contained safety data to support the use of the product in children between the ages of two months and two years." According to Peck, this study was "essential to approval" for the inclusion of children under two in the indication. FDA did not find the remaining studies essential, and consequently the agency denied extending full exclusivity for the OTC product "regarding the labeled use in patients older than two years," Peck's letter states. The original NDA for Nix was approved on March 31, 1986 based on two "pivotal studies," Peck's letter explains. Nix was indicated for "the single-application treatment of infestation with head lice...and their nits," and the labeling claimed that the drug was "safe and effective in children of two years of age and older."
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.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.