Perrigo
This article was originally published in The Tan Sheet
Executive Summary
Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)
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Private label extended release acetaminophen
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
Private label extended release acetaminophen
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
Private label extended release acetaminophen
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