A.L. LABS' PRIVATE LABEL CLOTRIMAZOLE TO BE PACKAGED, DISTRIBUTED BY BARRE/NMC

A.L. LABS' PRIVATE LABEL CLOTRIMAZOLE TO BE PACKAGED, DISTRIBUTED BY BARRE/NMC following the recent FDA approval of the generic version of Schering-Plough's OTC antifungal, Gyne-Lotrimin ("The Tan Sheet," July 26, In Brief). Baltimore-based Barre said it has no plans to contract a licensee or distributor any time in the near future to market its private label clotrimazole. The product, which is slated to appear on retail shelves by fall 1993, will be marketed under the Barre/NMC label as well as private labels, according to the company. The 45-gram tube of cream will either be packaged with a single applicator or seven disposable applicators. Barre is currently drafting labeling for some of its private label customers, the company said. Although it has not yet released any names, Barre said that it is selling the product into major chain drug, mass merchandiser and food store lines. Meanwhile, NutraMax is also planning to ship private label clotrimazole cream and inserts this fall following an agreement with an undisclosed supplier understood to be Miles ("The Tan Sheet" July 12, In Brief). Miles sells the OTC clotrimazole brand Mycelex-7. A.L. Labs signaled its interest in expanding its operations further in the OTC area in the company's 1992 annual report. "While we have benefited from the increased market size of pharmaceuticals which have become OTC products," the generic drug company stated, "we plan to establish a sales division to better serve and further penetrate this growing consumer market." In addition, the company is taking steps to augment its manufacturing capabilities for topical products. In March, A.L. Labs acquired Naska Pharmacal, a company with a modern manufacturing plan specializing in the production of oral liquids and topical ointments and creams ("The Tan Sheet" March 15, In Brief). The abbreviated new drug application for clotrimazole vaginal cream USP 1% was filed by NMC in December 1991 and was approved by FDA after a 19-month review on July 16. Barre/NMC supported the ANDA with "extensive clinical trials," the company said. Schering- Plough has effectively delayed the approval of clotrimazole ANDAs by petitioning the agency to require clinical trials for generic products in lieu of simpler and less expensive bioequivalence studies.