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The Food & Drug Administration last week approved Procter & Gamble Co.'s request to take its Femstat 3 yeast infection treatment over the counter, a move that comes as both the product and the category need a lift.

Femstat (butoconazole nitrate) has been available by prescription since 1986 and was developed by Procter-Syntex Health Products Co., a joint venture of P&G and Roche Holding. Sales for the first 11 months of 1995 totaled $9.87 million, according to Scott-Levin Associates, Newtown, Pa., a far cry from the $15.7 million recorded for 1991, the year Johnson & Johnson's Monistat 7 went OTC.

Researchers don't specifically track a category of products for treating vaginal yeast infections. However, Monistat is generally acknowledged as having about half the OTC market, and its sales of $111.6 million through Nov. 30 were flat, according to Towne-Oller & Associates, New York. "It's been a very competitive market," said a J&J spokesman.

Femstat will carry its prescription name with the number three added-emphasizing its three-day treatment vs. seven days for established OTC brands, such as category leader Johnson & Johnson's Monistat 7.

P&G wouldn't disclose media support for Femstat 3, to be handled by Leo Burnett USA, Chicago. But the product will be going up against Monistat 7, supported by $29.3 million from McCann-Erickson Worldwide, New York; Bayer Group's $15.6 million on Mycelex 7 through Tatham Euro RSCG, Chicago; and Schering-Plough Corp.'s $10.5 million on its Gyne-Lotrimin brand via William Douglas McAdams, New York, according to Competitive Media Reporting.

Because of such competitive marketing strength, industry observers were critical of P&G's plan to wait until spring to get Femstat 3 on shelves.

"I'm surprised it's taking them that long to get to market," said Paul Kelly, president of Silvermine Consulting, Westport, Conn., citing J&J and American Home Products, which got Pepcid AC and Orudis KT to stores within four to six weeks of FDA approval. "Schering and J&J have all kinds of opportunity to pre-empt them. We've seen .*.*. how important being quick is."

Indeed, the market went through heavy private-label competition in 1993, when J&J took matters in hand by cutting Monistat's price to $9 from about $16. Other brands quickly followed.

"J&J stopped private label in its tracks," said Gary Stibel, a principal with New England Consulting Group, Westport, Conn. Femstat 3 is to be competitively priced, though P&G declined to be specific.

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