Perrigo receives FDA approval for ANDA 75-077 Feb. 25 and will launch the product by July 31; the generic is equivalent to McNeil Consumer Healthcare's Tylenol Arthritis Extended Relief Caplets. Perrigo had expected approval for the 650 mg acetaminophen pain reliever/fever reducer before the end of 1999 (1"The Tan Sheet" Nov. 22, In Brief). The Allegan, Mich.-based private labeler's introduction of store brand extended release acetaminophen will likely disrupt sales of Tylenol Arthritis, which held a 2.5% dollar share of the internal analgesic tablet market in 1999 with sales of $66.8 mil., according to Information Resources, Inc. of Chicago
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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 recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
