Orally Dissolving Strips To Melt Away Heartburn? ANDA Suitability Sought
This article was originally published in The Tan Sheet
Executive Summary
An orally disintegrating strip form of Johnson & Johnson/Merck's Pepcid AC (famotidine 10 mg) could be heading towards the market if FDA looks favorably upon a pending ANDA suitability petition
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An orally disintegrating strip form of Johnson & Johnson/Merck's Pepcid AC (famotidine 10 mg) could be heading towards the market if FDA looks favorably upon a pending ANDA suitability petition. Approval of the proposal, filed by Lachman Consultant Services on behalf of an unnamed firm, would represent the first time orally dissolving strip technology was used for a drug, although the petition notes that several breath freshener products are marketed in this form. For example, Pfizer's Listerine PocketPaks strips, which claim to kill 99.9% of germs in 30 seconds, debuted in 2000 (1 (Also see "Cool Mint Listerine PocketPaks Breath Strips Slated For Summer Launch" - Pink Sheet, 28 Feb, 2000.), p. 3). Despite not having a drug precedent in strip form, the petitioner maintains the proposed product's "dosage form is directly analogous to the multitude of fast-dissolving and disintegrating tablets that have been approved by the agency." Several OTC drug tablets use quick-dissolve technology, including Bristol-Myers Squibb's Excedrin QuickTabs and Schering-Plough's Claritin RediTabs . Westbury, N.Y.-based Lachman Consultants submitted the citizen petition Aug. 4 to seek advice on whether a "change in dosage form, from a chewable tablet to an orally dissolving strip," is an appropriate subject of an abbreviated new drug application. The OTC would be equivalent to J&J/Merck's H2 antagonist, which was launched over the counter in June 1995. The heartburn remedy is the subject of a Paragraph IV filing submitted earlier this year (2 (Also see "Zyrtec-D Paragraph IV Application Submitted To FDA" - Pink Sheet, 9 Aug, 2004.), p. 6). The agency does not reveal the generic applicant. Labeling for the proposed product would be consistent with Pepcid AC labeling, save for "prevention of use" directions, according to the petition. Lachman explained this difference relates to a patent covering Pepcid AC, and that labeling remains consistent with generic forms of famotidine 10 mg. "The proposed product will provide an alternate dosage form that may prove to be more convenient for patients who have difficulty swallowing a tablet or who do not like to chew tablets," the submission points out. |