BOLAR'S GENERIC DILTIAZEM (CARDIZEM) FULL NDA

Executive Summary

BOLAR'S GENERIC DILTIAZEM (CARDIZEM) FULL NDA will be submitted to the FDA by the end of this year, Bolar President Robert Shulman announced at the firm's meeting May 5. Bolar has been working on the NDA for "at least two years", Shulman noted. Bolar's application is for q.i.d. dosage, the same dose schedule as Marion's Cardizem, Shulman indicated. The diltiazem patent expired in February, but Marion retains exclusive marketing rights under the 10 year "window" provision of the Waxman/Hatch Act. Under that provision, ANDAs for diltiazem and other pioneer products approved between 1982 and November 1984 are prohibited until November 1992. Approvals for full NDAs, however, are allowed. The announcement of the diltiazem NDA application is consistent with Bolar's aggressive strategy to gain approvals for the first generic versions of brandname products. In 1987, Bolar was the first company to receive approval for a generic equivalent to SmithKline's Dyazide under the ANDA approval procedures. Pharmakinetics Labs has been mentioned in the financial press as the institution which is possibly conducting bioequivalence studies for Bolar's diltiazem NDA application. Pharmakinetics announced in January that it was providing services toward an NDA for a new compound for a leading U.S. pharmaceutical company ("The Pink Sheet" Jan. 11, 1988, "In Brief"). Pharmakinetics acknowledged that Bolar is one of its clients.