Senior Editor, Consumer Health
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Latest From Malcolm Spicer
Claims that rendered the firms' products unapproved new drugs and were listed in FDA warning letters include "It’s basically an oral sunscreen … This would be especially useful for people who have had skin cancer, are at risk for skin cancer.” The firms FDA warned are Isocell North America Inc., Sunergized LLC, Pharmacy Direct Inc. and Napa Valley Bioscience LLC.
CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.
Nutrition and food safety watchdog group asks FDA to enforce against marketers of ginkgo supplements after ConsumerLab.com found that six of 10 ginkgo supplements it tested contained either less of the herb than advertised or different and cheaper plant material.
Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.
Nonprescription products containing ibuprofen can now only be marketed in the US through NDAs. No companies took advantage of a proposed ibuprofen addition to the the internal analgesic, antipyretic and antirheumatic OTC monograph, issued in 2002.
Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.