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McNeil's Nicotrol is first nicotine patch switched by FDA; will be in stores by July 18.
NICOTROL NICOTINE PATCH WILL BE ON SHELVES BY JULY 18, following July 3 approval from FDA for OTC marketing, McNeil Consumer announced. The transdermal patch will be available in a 15 mg strength to be used daily for six weeks. Nicotrol was unanimously recommended as safe and effective for over-the-counter use as a smoking cessation aid by FDA's Nonprescription Drugs Advisory Committee and members of the Drug Abuse Advisory Committee on April 19 ("The Tan Sheet" April 22, p. 1).
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.