Generic Drugs: No Need for Skepticism

Today, the number of generic drugs leaving the pharmacy far outweighs the number of brand-name drugs. This trend is projected to continue in the future as more patents of brand-name drugs run out. Once this occurs, companies may submit an application to the Food and Drug Administration (FDA) for generic drug approval. The FDA is responsible for classifying whether generic and brand-name drugs are equivalent. Standards for quality, safety, and efficacy must be met.

Some patients may feel uneasy about the equivalence of brand-name and generic drugs. Generic drugs can only be approved by the FDA for the same medical conditions and uses as the brand-name drug. They also must have the same route of administration, amount of active drug and dosage form as the brand-name drug. Differences that are acceptable include color, shape, flavor, packaging, preservatives and storage conditions.

Once the above considerations are met, generic drugs must then prove to have the same clinical effect in the body. This is determined by measuring the rate and extent of drug absorption in the blood. For approval by the FDA, these values must be within a narrow range of those found with the use of the brand-name drug. Although a range may be present, it does not pose a problem for the majority of generic drugs.

Some generic drugs that have been approved in the past year include:

Brand-Name

Generic

Plavix

Clopidogrel

Avapro

Irbesartan

Seroquel

Quetiapine

Lexapro

Escitalopram

Geodon

Ziprasidone

Lipitor

Atorvastatin

Zyprexa

Olanzapine

Levaquin

Levofloxacin

Nasacort

Triamcinolone

Since generic drugs go through this approval process to ensure equivalence to brand-name drugs, they can be considered both safe and effective for patient use.

By Katie Hovick, Drake University PharmD Candidate and Lindsey Batz, University of Iowa PharmD Candidate

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s