Sanofi says with Nasacort Allergy 24HR available at retailers nationwide and online, the firm withdrew its litigation against FDA, which appears to have slowed development of private-label equivalents.
A lawsuit fromSanofi that kept the labeling of its OTC switch Nasacort Allergy 24HR under wraps between approval and launch could be a model for delaying private-label competition.
Sanofi announced on Feb. 4 that Nasacort Allergy 24HR (triamcinolone nasal spray), approved as an OTC in October 2013 and marketed through its U.S
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
