Johnson & Johnson's McNeil Consumer Healthcare subsidiary could launch Zyrtec-D behind the counter before the end of the year. FDA approved the antihistamine and nasal decongestant for nonprescription use in adults and children 12 years and older Nov. 9. Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) has been available as a prescription drug since 2001. Under the Combat Meth Act, Zyrtec-D is required to be sold behind the counter because it contains pseudoephedrine, according to McNeil. J&J acquired OTC licensing rights for Zyrtec when it purchased Pfizer Consumer Healthcare in 2006...
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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.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
