FDAnews
www.fdanews.com/articles/152626-pfizer-seeks-more-be-requirements-for-generics-of-its-opioid-embeda

Pfizer Seeks More BE Requirements for Generics of Its Opioid Embeda

January 24, 2013
Pfizer is asking the FDA to add five additional bioequivalence (BE) recommendations for ANDA applicants referencing its pain drug Embeda. The company has “serious concerns” about the ability of generic applicants to effectively establish bioequivalence with the four “limited studies” currently recommended in FDA draft guidance, given the long-acting opioid’s unique delivery system.
Generic Line