Schering-Plough shipping Gyne-Lotrimin 3 within days of July 29 approval.
This article was originally published in The Tan Sheet
Executive Summary
SCHERING-PLOUGH SHIPPING GYNE-LOTRIMIN 3 TO TRADE following FDA's July 29 approval of the three-day OTC vaginal yeast infection treatment. The company said it plans to begin shipments of the clotrimazole product within days of the approval. Unlike other recently launched three-day treatments, Gyne-Lotrimin 3 is not an Rx-to-OTC switch product since it was never available as an Rx dosage regimen. Schering filed an NDA in September 1994.
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SCHERING-PLOUGH SHIPPING GYNE-LOTRIMIN 3 TO TRADE following FDA's July 29 approval of the three-day OTC vaginal yeast infection treatment. The company said it plans to begin shipments of the clotrimazole product within days of the approval. Unlike other recently launched three-day treatments, Gyne-Lotrimin 3 is not an Rx-to-OTC switch product since it was never available as an Rx dosage regimen. Schering filed an NDA in September 1994. Gyne-Lotrimin 3 will be sold as two separate SKUs: one containing three 200 mg clotrimazole inserts, and a "combination pack" containing three 200 mg inserts plus a 7 g tube of 1% clotrimazole cream for relief of external itching and vulvar irritation. The Schering-Plough product will be the third three-day vaginal yeast infection treatment to reach the market, following Femstat 3, launched in early April by Procter & Gamble ("The Tan Sheet" April 1, p. 14) and Johnson & Johnson's Monistat 3, launched a few weeks after its April 16 approval ("The Tan Sheet" April 29, p. 1). Labeling for Gyne-Lotrimin 3 is essentially the same as that of Femstat 3 and Monistat 3. For example, first-time yeast infection sufferers of "vaginal or vulvar itch and discomfort" are directed to consult their physicians to confirm diagnosis. Labeling also warns that the product may weaken latex in condoms and diaphragms, stating: "Do not rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using this product." Femstat 3 had sales of $16.5 mil. in its first three months, garnering a 7% share of the vaginal yeast infection market, according to Information Resources, Inc. For the 12 months ended June 30, J&J's Monistat 7 had a 48% share of the market. Sales during the period for Monistat 7 totaled $113.4 mil., representing a 5.7% drop from the previous 12 months. Combined private label products had the next largest share of the market -- 15.8% -- and sales of $37.2 mil. (down 2.7%). Bayer's Mycelex-7, with a 15.1% share of the market, had sales of $35.8 mil. during the period, representing a 15.9% decline. Schering's Gyne-Lotrimin seven-day treatment had a 13.1% share of the market, with sales down 26.2% to $30.9 mil., according to IRI. Sales for the overall vaginal anti-fungal category in food, drug and mass merchandise outlets totaled $236.1 mil. for the 12 months ended June 30, down 4.7% from the previous 12 months. |