Executive Summary

Barr's ANDAs for erythromycin delayed-release 333 mg capsule shaped and round shaped tablets were approved May 16, and its ANDA for erythromycin stearate 500 mg taba was approved May 15. Bar already markets erythromycin stearate 250 mg tabs. Barr will be the first generic firm to to sell erythromycin delayed-release 333 mg tab as a multisource product. Boots' E-Mycin and Abbott's Ery-Tab are marketed as branded versions of erythromycin delayed-release 333 mg and 250 mg tabs. Barr has alleged that FDA has intentionally delayed approval of its erythromycin delayed-release ANDAs as well as other applications in order to retaliate against the firm for testifying about problems with FDA's Division of Generic Drugs. FDA has told Barr that it must conduct a second bioequivalence study for its pending ANDA for a 250 mg tab. Barr received ANDA approval for the 500 mg tab in November 1988.