Emergency contraceptive could be considered for Rx-to-OTC switch in the coming years, the company indicates. The Rx kit, which includes four levonorgestrel .25 mg/ethinyl estradiol .05 mg pills as well as a pregnancy test and a patient information book, received FDA approval Sept. 2. Speaking at a same-day teleconference, Gynetics Chairman Roderick Mackenzie did not express an immediate desire to pursue a switch, citing market research showing women value the chance for product reimbursement and physician consultation, but said the company would "monitor this together with FDA for the next year or two. As we learn more, we are going to readdress the situation of whether going over-the-counter is appropriate." Rx Preven will be available nationwide in late September; a print/radio consumer ad campaign is planned for October. FDA has shown mild interest in oral contraceptives as switch candidates. An advisory meeting on the topic was scheduled for February 1993, but was postponed to gather input from interested groups...
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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.’
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
