P&G expects final approval of OTC Prilosec (omeprazole) for prevention of frequent heartburn early in the first quarter of 2003, firm says following Aug. 8 FDA letter deeming drug "approvable" pending label modifications and a label comprehension study. Company says FDA's correspondence gives it a "much better understanding of what is needed in a label comprehension study." In June, agency advisory committee members voted 16-2 in favor of switching the proton pump inhibitor OTC, but recommended significant labeling changes and an additional comprehension study (1"The Tan Sheet" June 24, 2002, p. 3). FDA's letter came three days after P&G told analysts during its Aug. 5 fiscal year-end earnings call that it hoped for final OTC approval before 2003 (2"The Tan Sheet" Aug. 12, 2002, p. 7)...
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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.’
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
