FDA reaffirms the therapeutic equivalence of Teva's extended-release bupropion tablets April 16 following a re-evaluation of the safety and efficacy for the antidepressant. FDA initiated the review of the generic version of GlaxoSmithKline's Wellbutrin XL (bupropion) after receiving 85 post-marketing reports in the first half of 2007. The majority of the reports involve loss of efficacy following a switch from the brand to generic product, which is manufactured by Impax. Other reports were for onset or worsening of side effects, consistent with the adverse effects in labeling. However, FDA concludes that Teva's 300 mg tablets, marketed as Budeprion XL, are bioequivalent and therapeutically equivalent to Wellbutrin XL, despite small differences in pharmacokinetic profiles. Impax is also approved for 100 mg, 150 mg and 200 mg dosages of extended-release bupropion. Other manufacturers of generic Wellbutrin XL include Sandoz, Anchen, Actavis and Watson
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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.
