Firm has pending ANDAs for generic versions of McNeil's Rx Concerta (methylphenidare hydrochloride) extended-release tablets in 18, 27, 36 and 54 mg formulations. McNeil's exclusivity for the pediatric hyperactivity deficit disorder drug was set to expire March 17, and the firm has filed a citizen petition with FDA "that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta," according to Andrx. McNeil put 300 sales reps behind the drug in 2000 (1"The Tan Sheet," April 24, 2000, In Brief)...
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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.’
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.
