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SANDOZ STRESSING SAFETY OF OTC TAVIST-1 AND TAVIST-D IN CONCOMITANT USE WITH ANTIBIOTICS AND ANTIFUNGALS FOLLOWING AUG. 21 APPROVAL; OCTOBER LAUNCH

Executive Summary

Sandoz is emphasizing the safety of OTC Tavist-1 and Tavist-D in concomitant use with antibiotic and antifungal medicines as the company prepares to introduce the antihistamine products in October. "Unlike some antihistamines currently on the market, Tavist- D's safety profile makes it compatible with concomitant antibiotic and antifungal therapies," Sandoz said in an Aug. 28 press release. "With a history of 25 mil. prescriptions, there have been no reported interactions with Tavist-D and antibiotics, including erythromycin and ciprofloxacin, ketoconazole, cimetidine and disulfiram," the company declared. The switch applications for Tavist-1 (clemastine fumarate, 1.34 mg) tablets and Tavist-D (clemastine 1.34 mg/phenylpropanolamine HCl, 75 mg) extended-release tablets were approved on Aug. 21. The company pursued the switch for eight years through several twists and regulatory setbacks. Both products were recommended for OTC status by FDA's Pulmonary-Allergy Drugs Advisory Committee on March 23 ("The Pink Sheet" March 30, p. 4). Two versions of clemastine fumarate -- Tavist-2, (2.68 mg tabs); and Tavist syrup (primarily for pediatric use) -- will remain prescription only. Retail cost for Tavist-1 will be $3.99 for blister packs of eight tablets and $6.99 for 16 tablets. The AWP price per tab for the product when bought in 100s was 63.8 cents (eight tabs would cost $5.10 at that price). Tavist-D 8-tab packs will cost $3.79 and 16-tab packs will sell for $6.59. The AWP per tab price (100s) was 79.5 cents or $6.36 for eight tabs. Sandoz notified the trade of the switch approvals during the week of Aug. 24 to begin the launch process for consumer sales in October. The emphasis on product safety plays the Sandoz product off against the recent publicity for drug interaction and overdosage concerns that have arisen with the leading prescription nonsedating antihistamines Seldane and Seldane-D from Marion Merrell Dow and Hismanal from Janssen. Both products are being relabeled to warn of possible cardiovascular adverse events. The Seldane relabelings specifically are tied to drug interactions from concomitant use with the antibiotic erythromycin and the antifungal ketoconazole. FDA's approval of the Tavist switch applications within two months after the Seldane and Hismanal relabelings indicates that the agency has a relatively high level of comfort with the Sandoz safety profile. FDA could easily have decided to hold up the clemastine decisions for a closer examination in the wake of the Seldane and Hismanal experiences. Consumer labeling carries warnings that Tavist-1 and Tavist-D "may cause drowsiness" and that "alcohol, sedatives, and tranquilizers may increase the drowsiness effect." The degree of drowsiness caused by clemastine was a major topic of debate at the March 23 advisory committee meeting, with committee members disagreeing on the need to highlight the drowsiness warning in labeling. Canadian OTC labeling says that drowsiness may occur "initially." The Tavist drowsiness issue also created problems for Sandoz in the past when a series of 1987 direct-to-consumer ads touting low drowsiness prompted FDA to dub them false and misleading. Sandoz subsequently cancelled the campaign. The safety concerns about the prescription products gives Sandoz a new tack for the launch this year. Tavist-D does carry a drug interaction precaution: "Do not take this product if you are presently taking a decongestant or prescription drug for high blood pressure or depression, without first consulting your doctor." The Sandoz applications for the switch, as described at the March advisory committee meeting, were based primarily on the products' long record of use. The company noted that it had sold 6 bil. units of Tavist-1 worldwide and 800 mil. units of Tavist-D. If the company did not include new studies for the switch application, it may face "me-too" house brand versions from generic producers in the near future. Lemmon has the only generic version currently approved. The OTC versions of Tavist will carry the same indications as the current prescription version. The packaging for OTC Tavist-1 says it "temporarily reduces runny nose and relieves sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies." The indications section of the package for OTC Tavist-D reads: "For the temporary relief of nasal congestion associated with upper respiratory allergies or sinusitis when accompanied by other symptoms of hay fever or allergies, including runny nose, sneezing, itchy nose or throat or itchy, watery eyes." Sandoz maintains that "clemastine fumarate is naturally long- lasting." That claim is backed up by the pharmacokinetics section in prescription labeling, where the activity of clemastine is described as reaching a peak within 5-7 hours and persisting for 10-12 hours and sometimes up to a full day. "Unlike other 12-hour OTC medicines, clemastine is not time-released therefore its full, potent dose acts immediately to relieve [symptoms]," Sandoz declared in its press release announcing approval. Prescription labeling for Tavist-1 states: "The inherently long duration of antihistaminic effects of Tavist has been demonstrated in wheal and flare studies." The OTC labeling for Tavist-1 continues to carry the asthma use warning. The warning against use in individuals with asthma is an across-the-board contraindication for OTC and prescription antihistamines that has remained despite FDA's Pulmonary-Allergy Drugs Advisory Committee recommendation in June 1990 that the asthma contraindication be removed from antihistamine labeling. The October launch of OTC Tavist will be supported by an ad campaign budgeted at approximately $40 mil. from Bloom FCA, New York City. The market introduction of the switch products will have to meet the high expectations of Sandoz' Swiss management, which is counting on Tavist to be the cornerstone of its plan to build up its U.S. OTC business ("The Pink Sheet" Dec. 23, 1991, p. 5). Tavist can build on the Sandoz launch of TheraFlu which quickly created a new category of hot-liquid cough/cold/flu products in the U.S.
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