Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Dec 21, 2007

FDA Finds Satisfactory Resolution of Akorn cGMP Issues

  • Akorn reports positive results from a recent FDA cGMP compliance inspection of the Decatur, IL manufacturing facility. This inspection also served as a preapproval inspection (PAI) for Akorn’s new lyophilization operation.

    As a result of this inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial, and lyophilization production filling suites in Decatur.

    According to Akorn, the agency found satisfactory resolution of past cGMP issues. The FDA District of Chicago office also confirmed they had reported to the FDA Center for Drug Evaluation and Research that the firm’s responses to the subject inspection appear to be acceptable.



Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »