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GlaxoSmithKline (GSK) moved one step closer to marketing it anti-obesity drug Xenical without a prescription after an FDA advisory panel late Monday overwhelmingly recommended the agency approve the company’s application to sell the drug OTC.
FDA drug reviewers have expressed doubts about the benefits of allowing consumers to purchase GlaxoSmithKline’s (GSK) anti-obesity drug Xenical without a prescription.
An unreleased federal report bolsters allegations that the FDA made a political rather than a scientific decision when it delayed Barr Pharmaceuticals’ application to sell the Plan B contraceptive without a prescription, congressional sources say.
A preliminary federal review of the FDA's handling of Barr Pharmaceuticals' request to sell the Plan B contraceptive without a prescription bolsters allegations that politics rather than science drove the agency's decisionmaking on the controversial application, congressional sources say.
An unreleased federal report bolsters allegations that the FDA made a political rather than a scientific decision when it delayed Barr Pharmaceuticals’ application to sell the Plan B contraceptive without a prescription, congressional sources say.
Barr Pharmaceuticals has entered into a preliminary agreement with Organon and Savient Pharmaceuticals to buy rights to contraceptive Mircette. The agreement, pending FTC approval, effectively ends a drawn-out patent suit over Barr’s generic version of the drug.
The FDA has asked the public to weigh in on how it determines when a drug may be marketed as both a prescription and an OTC product -- a move that was prompted by the FDA's inability Aug. 26 to rule on Barr Pharmaceuticals' OTC application for the Plan B emergency contraceptive.
Two Democratic senators have asked HHS Secretary Michael Leavitt to launch an investigation into reports that a conservative member of an FDA advisory committee was asked to write a “minority report” explaining why the agency should reject OTC status for the emergency contraceptive Plan B.