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.’
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
