Allendale Pharmaceuticals expects an ad campaign in Spring 2006 to support the official national launch of the Today Sponge, the firm says. The OTC contraceptive, which contains nonoxynol-9, is now available for sale through drugstore.com, the firm adds. The product is not fully distributed nationwide yet due to capacity constraints. Currently the product is available at Walgreens, Rite-Aid and CVS stores. FDA recently re-approved the contraceptive product in April, 10 years after American Home Products (now Wyeth) removed it from the market due to quality control concerns. The sponge became available online through the Allendale, N.J.-based firm's website in late August and began reaching drugstores in September (1"The Tan Sheet" April, 25, 2005, 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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President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.