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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

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

A less severe cough and cold season contributed to lower sales in the cough/cold and analgesic categories during the third quarter ended April 1, the private labeler reports. Perrigo credits new product sales, particularly its private label nicotine patch, for partially offsetting the seasonal decline. A softening vitamin market and the loss of two large accounts negatively impacted nutritional sales. On a pro forma basis, OTC and nutritional third quarter sales were $181.5 mil., down 9.7% from a year ago. Perrigo's disposal of $11 mil. in expired inventory during the quarter, approximately $7 mil. more than anticipated, also affected bottom line results. The Allegan, Mich.-based company expects to begin shipping private label extended release acetaminophen by June 30 (1"The Tan Sheet" March 6, In Brief). Perrigo also announced it has settled a lawsuit filed by The Grow Group, the company's former owner, alleging breach of fiduciary duties by certain Perrigo officers

Perrigo

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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