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

TAVIST AND TAVIST-D OTC SWITCH APPLICATIONS FROM SANDOZ

Executive Summary

TAVIST AND TAVIST-D OTC SWITCH APPLICATIONS FROM SANDOZ will be reviewed by FDA's Pulmonary-Allergy Drugs Advisory Committee at its March 23 meeting, according to a notice in the Feb. 25 Federal Register. The applications will be reaching the advisory committee review just about two months after the approval of the initial ANDAs for generic versions of the prescription Tavist single ingredient antihistamines. Lemmon's clemastine fumarate ANDA was approved on Jan. 31 ("The Pink Sheet" Feb. 17, T&G-4). Dura Pharmaceutical's Pentyde (pentigetide) nasal spray for seasonal rhinitis and Carter-Wallace's Organidin (iodinated glycerol) are also on the agenda for the March 23 meeting. The Pentyde NDA review will be the second advisory committee review for the peptide. A subcutaneous version received an unfavorable advisory committee reivew in 1988. The NDA for the nasal spray received a nonapprovable letter a year ago, according to information disclosed by Dura in a recent public offering ("The Pink Sheet," Jan. 13, T&G-5). The review of Organidin, an expectorant, is described by the FDA notice as a review of the "marketing status" of the product. The Tavist applications represent a second try for OTC status by Sandoz. The company withdrew a supplemental application for OTC status for the products in early September 1986. As part of that application, Sandoz attempted to include a claim for clinically proven low drowsiness. FDA has said in the past that it objected to that claim for clemastine fumarate ("The Pink Sheet" Oct. 26, 1987). Subsequent to withdrawal of the OTC supplemental application, the company ran a short-lived advertising campaign in consumer publications but addressed to MDs. That campaign, in the autumn of 1987 for the 1.34 mg. version of the product (Tavist-1), cited "high effectiveness" and "low drowsiness." The company stopped running the ad after objections from FDA but declared that the claim was "appropriate" and was part of the approved labeling. Advertising issues are occasionally raised by FDA's Rx advisory committees when reviewing switch applications. With the Tavist background, it is possible that the March 23 session could include a discussion of the effect on the safety profile of the product of potential consumer ad approaches. Another potentially significant question about the switch could relate to the extent of new trials for the OTC application. If Sandoz submits new clinical trials, it should earn exclusivity for its OTC offering. If it does not and does not change the dosage or format, then FDA may be obligated to let the generic versions of the single ingredient switch to OTC. There are no approved generic versions of the clemastine/phenylpropanolamine combo (Tavist-D), which is the largest volume item in the Tavist line for Sandoz. The company's Swiss management has recently highlighted the pending switch as a major event in an effort to build the Sandoz OTC business in the U.S.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS020501

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