Private label extended release acetaminophen
This article was originally published in The Tan Sheet
Executive Summary
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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Perrigo Extended-Release Acetaminophen Launch Delayed By QC Issues
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Perrigo Extended-Release Acetaminophen Launch Delayed By QC Issues
Perrigo has postponed its plans to market private label extended-release acetaminophen until it can resolve quality control issues outlined in a recent FDA warning letter.
Perrigo Extended-Release Acetaminophen Launch Delayed By QC Issues
Perrigo has postponed its plans to market private label extended-release acetaminophen until it can resolve quality control issues outlined in a recent FDA warning letter.