J&J Monistat 3 Combination Pack Cream Extension Clears FDA
This article was originally published in The Tan Sheet
Executive Summary
Johnson & Johnson Personal Products will begin shipping a Monistat 3 Combination Pack cream line extension to food, drug and mass outlets in the second quarter, the firm said Feb. 9.
You may also be interested in...
Monistat Labeling To Carry Vaginal Miconazole/Warfarin Interaction Warning
Johnson & Johnson Personal Products will update the labeling for its miconazole-containing Monistat 3 and Monistat 7 yeast infection treatments within the year to note the possible interaction between vaginal miconazole and the Rx blood-thinning medication warfarin.
Private label miconazole combo packs
Alpharma receives approval April 16 for ANDA 74-926 and Perrigo, April 20 for ANDA 75-926, allowing both to market three-day miconazole vaginal antifungal treatment combination packs. Equivalent to the reference drug J&J's Monistat 3 Combination Pack, each contains three 200 mg miconazole nitrate suppositories and a 9 g tube of 2% miconazole nitrate cream. Waxman/Hatch marketing exclusivity for Monistat 3 ended April 16, opening up competition for the brand's 5.6% dollar share, reported by Chicago-based Information Resources, Inc. to be worth nearly $68 mil. at U.S. food, drug and mass merchandisers for the 52 weeks ended March 28
J&J Monistat 1 joins Vagistat-1 in one-day yeast infection treatment market.
MONISTAT 1 ENTERING ONE-DAY YEAST INFECTION TREATMENT MARKET under a licensing agreement between Johnson & Johnson and Bristol-Myers Squibb, the patent holder of the 6.5% tioconazole formulation. Bristol-Myers' Vagistat-1, which also contains 6.5% tioconazole, has been the sole entrant in the one-day vaginal yeast infection market until now. In stores nationwide starting June 15, Monistat 1 is being distributed by J&J's Personal Products Company.