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

SmithKline Tagamet HB receives FDA approval for new dosing directions.

This article was originally published in The Tan Sheet

Executive Summary

TAGAMET HB "RIGHT BEFORE" EATING DIRECTIONS FOR HEARTBURN PREVENTION approved by FDA June 5, SmithKline Beecham said. The new dosing directions for the OTC H2 antagonist cimetidine for heartburn say: "For prevention of symptoms, swallow one tablet with a glass of water right before or anytime up to 30 minutes before eating food or drinking beverages that cause heartburn." Current labeling for the SmithKline Beecham cimetidine 200 mg acid blocker directs users to take one tablet 30 minutes before eating or drinking beverages for prevention of heartburn. SmithKline filed a supplemental NDA for the new dosing directions in June 1997.
Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS088575

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