Alpha Therapeutic may continue distribution of albumin and IGIV reworked products under consent decree.

Executive Summary

ALPHA THERAPEUTIC MAY CONTINUE DISTRIBUTION OF ALBUMIN AND IGIV PRODUCTS using reworked or rejected lots "only to the extent that such practices are explicitly provided for in valid product license applications held by Alpha and approved by CBER," states a consent decree signed by the company and FDA Jan. 27. Alpha must submit new validation data within six months to FDA. If the agency finds the data are insufficient it may request that the company stop distribution of the albumin (Albutein) and IGIV (Venoglobulin-S) products. The company says that it holds "valid product licenses for IGIV and Albumin which explicitly provide for these practices."