Beconase switch review: FDA Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees scheduled Sept. 19 consideration of the proposed Rx-to-OTC switch of the beclomethasome dipropionate nasal spray .042% is postponed, according to Glaxo. In order to address some issues raised in its discussions with FDA, Glaxo has requested that the meeting be postponed for an undetermined period of time. Glaxo had been planning to present studies in support of the switch at the meeting ("The Tan Sheet" Aug. 4, p. 1). NDA 20-840, filed by Glaxo Wellcome in December, is for OTC treatment and prevention of seasonal allergic rhinitis symptoms in people over the age of 12. If approved, the OTC nasal spray will be marketed by Warner-Lambert under the firms' joint venture. Schering-Plough also has an NDA pending for a product -- Vancenase -- with the same active ingredient at the same dosage, but had postponed its committee review in September 1996 to allow time for additional data to be analyzed and presented to the committees ("The Tan Sheet" Sept. 30, 1996, p. 9)...
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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.
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