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SIDMAK "AB-RATED" THEOPHYLLINE CONTROLLED-RELEASE APPROVED

Executive Summary

SIDMAK "AB-RATED" THEOPHYLLINE CONTROLLED-RELEASE APPROVED April 30, making the second generic competitor to Key/Schering's Theo-Dur. The approval covers Sidmak Labs' controlled-release theophylline tablets in 100, 200 and 300 mg strengths. Announcing the approval, Sidmak said that "well-controlled bioequivalency studies have demonstrated that all strengths of theophylline/Sidmak are completely interchangeable with Theo-Dur tablets." Sidmak submitted five bioequivalence studies to FDA that show its theophylline is bioequivalent to the Key/Schering product. Sidmak tested the 100 and 200 mg doses of its generic theophylline against Theo-Dur 100 and 200 mg doses in multiple-dose, two-way crossover studies. The 300 mg dose was tested using a once-daily administration and a twice-daily regimen. Another study investigated the effects of food on theophylline's absorption. Forest conducted similar bioequivalence studies with its generic controlled-release theophylline, Theochron, in support of the first "AB"-rated dosage forms for Key's Theo-Dur. The Forest products, marketed by its Inwood Labs subsidiary, have carried AB ratings since January 1989. Schering has challenged the bioequivalence of Forest's theophylline products in meetings with the FDA and through Theo-Dur promotions, which FDA determined were "false and misleading." Sidmak plans to begin shipping its theophylline product in approximately two weeks. The company said that its price for the theophylline tablets will be 25% to 30% less than the average wholesale price (AWP) for Theo-Dur. Sidmak noted that its product also will be competitively priced to Forest's AWP for Theochron. Sidmak's theophylline will be available in bottles of 100's, 500's and 1,000's.
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