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 remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
