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PROPRANOLOL SUSTAINED RELEASE ANDA APPROVAL CRITERIA

Executive Summary

PROPRANOLOL SUSTAINED RELEASE ANDA APPROVAL CRITERIA should include "the ability to reproducibly achieve minimum (24 hour) plasma concentrations at least as high as an equipotent dosage of Inderal LA (propranolol HCl) long acting capsules," Ayerst said in a recent petition to FDA. The petition recommends four criteria for FDA adopt in evaluating ANDAs for propranolol HCl sustained release products. Other ANDA approval criteria recommended by Ayerst are: (1) "The ability of a product to reproducibly deliver plasma propranolol levels at the same initial rate and to the same extent as the listed drug, Inderal tablets, having similar AUC's (80-120%) over a 24 hour dosing interval measured at steady state"; (2) "The demonstration of a product's slow release characteristics as evidenced by comparison to the listed drug's release profile and an absence of 'dose dumping'"; and (3) "Demonstration of similar plasma concentrations, when compared to the listed drug, at the two hour time point with these values being compared statistically." Ayerst asserted that "applying the same standards and criteria to all such ANDAs seeking approval is important to assure that all such products will indeed be bioequivalent to the listed drug." The firm stated that "the approval of different sustained release propranolol HCl products should not be based upon requirements which vary significantly from product to product." The firm noted in its petition that four petitions have been submitted to FDA requesting permission to file ANDAs for sustained release propranolol capsule products. In November, Ayerst submitted an ANDA suitability petition for a "sequential" release Inderal capsule product that utilizes a different release mechanism than its controlled release Inderal LA. ANDA suitability petitions were also submitted by Martec, Elan and Fred Landsman. Ayerst's request for uniform approval standards is the second time the firm has petitioned FDA to revise its criteria for approval of generic propranolol products. In July, Ayerst petitioned FDA to revise its guidelines for generic immediate release propranolol HCl products to include additional tests to assure bioequivalence. The agency approved Lederle and Chelsea ANDAs for propranolol tablet products seven days after receiving Ayerst's July 24 petition.

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