FDA Approves Roxane Labs ANDA for Perindopril Erbumine Tablets
Wed, 11/11/2009 - 3:39am
Roxane Laboratories, Inc.announced today the approval of its Abbreviated New Drug Application (ANDA)for Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the U.S. Food and DrugAdministration. The product is available in bottles of 100 for immediateshipment to wholesalers and pharmacies nationwide. Roxane Laboratories' Perindopril Erbumine Tablets are AB rated to ACEON(perindopril erbumine) tablets. Annual sales of ACEON are approximately $24.1Million.