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MARION MERRELL DOW’s CARDIZEM CD WILL BE AVAILABLE BY MID- JANUARY

Executive Summary

MARION MERRELL DOW's CARDIZEM CD WILL BE AVAILABLE BY MID- JANUARY after a Dec. 27 approval, the company announced Dec. 30. The once-a-day extended release treatment for hypertension is the company's fourth diltiazem formulation, following Cardizem, Cardizem SR, and Cardizem Injectable. The injectable formulation of the drug, indicated for atrial fibrillation or atrial flutter and paroxysmal supraventricular tachycardia, was approved in October ("The Pink Sheet" Oct. 28, In Brief). Cardizem, which has been on the market since 1982, is indicated for angina and is taken four times daily. Cardizem SR, which has been available since 1989, has an identical indication to Cardizem CD but must be taken twice daily. Marion Merrell Dow Chairman and CEO Joseph Temple stressed the importance of the three years exclusivity the new formulation will enjoy at the Mabon Securities Research Conference in December ("The Pink Sheet" Dec. 9, p. 13). The company's ANDA exclusivity for immediate release Cardizem expires in November 1992. The calcium channel blocker's NDA (20-062) was approved in 180 mg, 240 mg and 300 mg tablet formulations. Shipments of the drug already have begun, the company said; the drug will be priced at a slight discount to Cardizem SR and a more substantial discount to Cardizem. The contraindications and warnings for the drug are identical to those of the SR formulation. MMD is preparing to submit a supplemental NDA for a Cardizem CD angina indication the week of Jan. 6-10. A similar supplemental NDA for Cardizem SR has been pending since May 1990 and is expected to receive approval "any time," the company predicted. Immediate release Cardizem is indicated for angina. FDA is said by MMD to have expressed interest in an accelerated review of the Cardizem CD angina application. Cardizem SR will remain on the market only until an angina indication for Cardizem CD is approved, MMD said. The NDA for Cardizem CD was filed in February 1990. The drug was recommended for approval by FDA's Cardiovascular and Renal Drugs Advisory Committee in March ("The Pink Sheet" March 18, p. 4). Cardizem CD became "approvable" on Oct. 10, just six days after Cardizem Injectable reached the same status ("The Pink Sheet" Oct. 14, In Brief).

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