Choosing a Generic Antidepressant

Bret Stetka, MD; Gregory Geba, MD, MPH; Lawrence X. Yu, PhD

Disclosures

February 04, 2013

Editorial Collaboration

Medscape &

In This Article

Choosing a Generic and Future Monitoring

Medscape: How would you recommend navigating generic substitutions with bupropion at this point?

Dr. Geba: Health professionals and consumers can be assured that the FDA-approved generic drugs meet the same quality standards as the innovator drug. A generic drug is the same as the brand-name drug, in terms of dosage, strength, and quality. The manufacturers need to demonstrate, among other things, that the product is bioequivalent to an FDA-approved reference listed drug (RLD) and, therefore, should be comparable to other generic drugs that are bioequivalent to the same reference drug. We believe that any differences between generic drugs are not clinically important in the vast majority of patients.

The generic drug has to show a similar rate and extent of absorption of the therapeutic ingredient (ie, it must meet established statistical parameters), as assessed by bioequivalence testing conducted using appropriate methodology such as that specified by the FDA in the bioequivalence guidance on the FDA Website -- and that is why we are highly confident in the high quality of these generic drugs and their interchangeability. That is why we require bioequivalence studies -- to ensure that they can be interchanged for the innovator.

For the other generic versions of bupropion XL 300 mg, we have no data suggesting that they are not bioequivalent to the RLD; however, we have asked the other sponsors to do further studies to assess the bioequivalence of these products. The Agency will review the data from the additional bioequivalence studies when the data are received and, if warranted, take additional steps. Patients taking bupropion should contact their healthcare provider if they have any questions or concerns about this medication.

Prescribers should feel confident that patients are getting safe and effective drug products regardless of whether the patient receives the innovator or generic product. Ultimately, prescribers, of course, should prescribe what they think would be most beneficial for the patient. The FDA is not involved in regulating the practice of medicine.

Medscape: Moving forward, how will the FDA continue to monitor this area?

Dr. Geba: We will continue to be vigilant in monitoring adverse event reports for potential signs of safety, efficacy, or quality issues with all marketed drug products, including generic drugs, and take appropriate actions to address any problems that we may identify.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....