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Executive Summary

BOLAR TRANSDERMAL NITROGLYCERIN PATCH WILL BE LAUNCHED IN FOUR TO SIX WEEKS, the company said following FDA's conditional approval of the product April 10. Bolar is the first generic company to enter the transdermal nitroglycerin market, which currently is made up of Ciba-Geigy's Transderm-Nitro, and Key's Nitro-Dur, and Searle's Nitrodisc. Bolar's product, trademarked NTS (nitroglycerin transdermal system), is available in dosages of 5 mg/24 hours (62.5 mg/10 cm2) and 15 mg/24 hours (187.5 mg/30 cm2). The price to whslrs. is $12.55 for the 5 mg dosage, and $15.50 for the 15 mg dosage, both sold in boxes of 30. Bolar's nitroglycerin is manufactured by Hercon Labs, a division of HealthChem. The South Plainfield, N.J.-based Hercon is a research firm developing transdermals. Hercon initially developed the patch, filed an ANDA for it, and subsequently transferred the ANDA to Bolar. Bolar has exclusive rights to NTS in the U.S. while Hercon has European rights. Bolar said Hercon is also developing a patch for another unspecified Bolar product. A pilot study on the second patch involving six to eight people is currently in progress, Bolar noted. NTS is the first Hercon product to reach the market. Bolar's nitroglycerin approval is conditional, as are the three other transdermal products on the market, pending completion of a transdermal nitroglycerin efficacy study by the current mfrs. Key is trying to differentiate its product with a new adhesive technology. The firm's Nitro-Dur II, which incorporates nitroglycerin in the patch adhesive, was approved by FDA in December.



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