Humibid Plus: Menley & James 400 mg guaifenesin/60 mg pseudoephedrine expectorant/decongestant to ship nationwide, the Memphis, Tenn.-based company says. A 200 mg guaifenesin/30 mg pseudoephedrine version launched last year to seven West Coast states ("The Tan Sheet" March 25, 1996, p. 7); Humibid Plus will replace that version. The product will be available in blister-packed 12- or 24-caplet versions. National radio ads are slated for the product, which should be on shelves by September, the company says...
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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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MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.
EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.
The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.