Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



Pepcid AC ANDA?

An FDA response letter dated July 6 deems that famotidine 10 mg (J&J/Merck's Pepcid AC) in an orally dissolving strip formulation is suitable for ANDA submission. Approval of the application would mark the first time the strip technology would be used to deliver a drug, though many breath fresheners including Pfizer's Listerine PocketPaks already are available in the formulation. The petition, filed by Lachman Consultant Services on behalf of an unnamed firm, was submitted in August 2004 (1"The Tan Sheet" Aug. 16, 2004, p.10)...

Pepcid AC ANDA?

An FDA response letter dated July 6 deems that famotidine 10 mg (J&J/Merck's Pepcid AC) in an orally dissolving strip formulation is suitable for ANDA submission. Approval of the application would mark the first time the strip technology would be used to deliver a drug, though many breath fresheners including Pfizer's Listerine PocketPaks already are available in the formulation. The petition, filed by Lachman Consultant Services on behalf of an unnamed firm, was submitted in August 2004 (1"The Tan Sheet" Aug. 16, 2004, p.10)...

Pepcid AC ANDA?

An FDA response letter dated July 6 deems that famotidine 10 mg (J&J/Merck's Pepcid AC) in an orally dissolving strip formulation is suitable for ANDA submission. Approval of the application would mark the first time the strip technology would be used to deliver a drug, though many breath fresheners including Pfizer's Listerine PocketPaks already are available in the formulation. The petition, filed by Lachman Consultant Services on behalf of an unnamed firm, was submitted in August 2004 (1"The Tan Sheet" Aug. 16, 2004, p.10)...

Related Content

Topics

UsernamePublicRestriction

Register

PS097175

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel