On May 7, 2018, Impax Laboratories, Inc. combined with Amneal Pharmaceuticals, Inc. (NYSE:AMRX) to create a dynamic company powered by a robust U.S. generics business and growing branded franchise. Today, we are working to integrate our business into the new Amneal and are excited about our future as one company.
In the meantime, there is no change to our Adverse Event reporting procedures. We continue to collect, review and report all adverse events and other safety findings, associated with the use of Impax’s investigational and marketed products.
Impax is dedicated to the management of the benefit risk profile associated with the administration of Impax’s commercial and investigational products to optimize patient safety.
What is an Adverse Event?
The FDA defines an Adverse Drug Experience as “any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following:
- An adverse event occurring in the course of the use of a drug product in professional practice
- An adverse event occurring from drug overdose whether accidental or intentional
- An adverse event occurring from drug abuse
- An adverse event occurring from drug withdrawal; and any failure of expected pharmacological action
The following should be reported to Impax whether or not they are associated with an adverse event:
- Use of an Impax product while pregnant and/or breastfeeding
- Off-label use of an Impax product relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the approved product information
- Accidental or intentional medication errors or overdose of an Impax product
- Misuse, where the Impax product is intentionally and inappropriately used not in accordance with the approved product information
- Abuse, which is, persistent or sporadic, intentional excessive use of a medicinal product
- Reports of patient death after exposure to an Impax product where no other details are provided
- Occupational exposure to an Impax product
- Transmission of an infectious agent through a contaminated Impax product
Follow the link below for the Impax Adverse Event and Product Complaint Report Form: http://ae.impaxlabs.com
You can also use the following to report an adverse event:
Phone: (877) 99-Impax (46729), option 2
Phone: (510) 240-6450, option 2
31047 Genstar Road
Hayward, CA 94544
Attention: Medical Affairs
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call (800) FDA-1088.