What testing has been done to ensure that the extended lot of antivenin can be used?
On April 19, 2010, Pfizer Inc. responded to a request for clarification of testing of the antivenin. “Antivenin Coral Snake has continued to maintain its quality attributes for approximately 2 years after expiration. Pfizer Inc. is currently planning for additional testing to determine whether the expiration dating may be extended again. Testing includes the product, closure and excipients. The FDA is aware of all testing performed. The FDA must review and approve all of the test results prior to FDA granting an extension of the expiration dating. In addition to tests of physical appearance (lyophilized and reconstituted), there is chemical testing of the product that includes potency and pH. Sterility, moisture and vacuum tests are also performed to give information on the integrity of the closure system.” Note: Excipients refers to inactive ingredients added to as a vehicle or a carrier of the active ingredient.
