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

Ibuprofen NDA approval

This article was originally published in The Tan Sheet

Executive Summary

Banner Pharmacaps' 505(b)(2) application (NDA 21-472) for ibuprofen 200 mg softgels approved by FDA Oct. 18. Product carries same indication as Wyeth's Advil Liqui-Gels. Banner says 505(b)(2) filing was necessary because there is no approved OTC ibuprofen with same dosage form and same active ingredient that would have allowed an ANDA filing. Advil Liqui-Gels have the same pharmacokinetic profile but contain partially titrated potassium salt of ibuprofen. Banner's product uses the free acid form of ibuprofen - the same as that found in standard ibuprofen tablets, caplets - but offers a different delivery form. Banner plans to partner with other firms to bring newly approved version to market...

You may also be interested in...



Banner naproxen petition

Banner Pharmacaps requests FDA allow filing of ANDA for naproxen sodium softgel capsules with same indication as Bayer's Aleve but different dosage form. In recent citizen petition to agency, Banner notes proposed naproxen softgel contains same active ingredient, same strength and same route of administration as Aleve tablets, will be labeled with same conditions of use but will differ with respect to dosage form, inactive ingredients and manufacturer contact information. High Point, N.C.-based firm recently received FDA approval for softgel version of Wyeth's Advil Liqui-Gels (1"The Tan Sheet" Oct. 28, 2002, In Brief). Leiner will package, market the 200 mg ibuprofen softgels in 20-, 40-, 80-, 135-, 200-count packages, as well as twinpacks of the 135-count for club outlets, generic firm says Nov. 14...

99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

BrightGene Bets On Remdesivir Amid Patent Questions

Despite many uncertainties, Suzhou-based BrightGene sees a bet on generic remdesivir worthy of a $700,000 investment.

Topics

UsernamePublicRestriction

Register

PS094697

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