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

What About Other Generic Formulations?

Medscape: Are there plans to conduct bioequivalence studies with other generic formulations?

Dr. Geba: As noted in previous statements, the FDA has asked the other sponsors of generic bupropion XL 300 mg products to conduct studies to assess the bioequivalence of their 300-mg extended-release bupropion tablets to Wellbutrin XL 300 mg.

Medscape: Are those trials completed or are they still ongoing?

Dr. Geba: The FDA asked those manufacturers to complete their studies in 6 months.

Medscape: There have not been as many case reports with the other formulations, correct?

Dr. Geba: Generally, the number of adverse event reports involving generic bupropion hydrochloride 300-mg products has decreased over time.

Medscape: Can you speak to selective serotonin reuptake inhibitors (SSRIs), the most commonly prescribed antidepressant class? Have postmarketing surveillance reports highlighted any concerns particular to this class of drugs?

Dr. Geba: One of the main missions of the Center for Drug Evaluation and Research is to monitor the safety and effectiveness of drugs that are available to the American public. In order to meet this goal, the FDA has many postmarketing programs that monitor marketed drug products for adverse events. The FDA has not received information relating to the safety or efficacy of SSRIs that would cause us to be concerned about them as a class.

Medscape: While the issue of brand-generic substitution receives substantial attention, our readers indicated in the recent survey of prescribers mentioned earlier that they were equally concerned about generic-generic substitutions and potential variance in production quality and ingredients among manufacturers. How does the FDA monitor varying generic manufacturers to ensure uniform production standards?

Dr. Geba: Theoretically, if each generic has to meet the same standard by demonstrating bioequivalence to the same reference drug, then, in essence, they are being compared. We are quite confident that, on the basis of those standards, generic products of the same formulation will be similar to each other.

Dr. Yu: Essentially, whether the drug is a generic or an innovator product, the same quality standards for identity, potency, purity, and stability are required. Generic quality is also ensured because we require that generic manufacturers adhere to the same Current Good Manufacturing Practice regulations as innovator products.

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