That puts Tavist-1 and Tavist-D into the $1.79 billion cough/cold category, where some older antihistamines have been for years.
Trying to leverage the news to its advantage, a new TV spot for Tavist from Publicis/Bloom, New York, claimed: "For the first time in history, an FDA advisory committee panel has concluded that a 12-hour antihistamine has been proven to work on colds."
But the effort was thwarted immediately when SmithKline Beecham, marketer of Contac, challenged the ad with the National Advertising Division of the Council of Better Business Bureaus.
NAD rejected the commercial because the FDA is not to be referenced in advertising.
NAD saw no problem with another Tavist spot carrying the claim, "The only one with proven cold and allergy relief."
When Tavist was approved to cross from prescription to over-the-counter in August 1992, it received no automatic cold indication like those products before it because the FDA had begun to question doing so without supporting evidence. So Sandoz conducted its own research specifically addressing antihistamines' ability to treat cold symptoms to win the claim. Other brands have not had to provide studies.
"The issue is still under review," said Ann Mustafa, supervisory chemist of OTC drug products division at the FDA. "If you were in the marketplace prior to the review, you may remain in the market with the claim" until a decision is reached, perhaps within the next year.
In the meantime, industry observers question entering the already overwhelmed cough/cold shelf, where sales are down 3.6%.
"Cough/cold is a very crowded category and I don't think it's going to do them much good at all," said Ben Ball, executive director of consultancy Dechert & Hampe. "Consumer reaction to extended relief for allergy/sinus was not as strong as expected, and the brand isn't established well as `powerful relief.' It's very difficult to change horses."
Sandoz, still awaiting governmental approval of its transformation with Ciba-Geigy Co. into Novartis, supported Tavist with $25 million in media ads in 1995.
Sales of No. 2-ranked Tavist slid 25.3% to $69.3 million, according to Information Resources Inc. for the year ended Sept. 29, in the $637.5 million allergy/sinus category, which was down 5.6%.