Sep 17

FDA Approves Botox Cosmetic for New Intended Use

On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here.

The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA approves drugs for certain indications, or conditions, commonly known as intended uses. To be approved by the agency for a particular use, the drug sponsor must submit an application to the FDA demonstrating that the drug is safe and effective for the particular intended use.

Doctors commonly prescribe legally marketed drug products for indications not in the approved labeling, however. Botox Cosmetic, for example, was frequently used by doctors to treat crow’s feet prior to being approved for this intended use. This “off-label” use does not require approval by the FDA as long as the intent is the practice of medicine and the use is based on the doctor’s sound medical judgment. In comparison, the FDA typically prohibits the direct marketing of FDA-approved drugs for indications other than those included on the drug’s labeling. Accordingly, while such a limitation is not placed on physicians, the FDA prohibits drug sponsors and marketers of drug products from promoting products for intended uses other than those that are approved by the agency.

In sum, Botox Cosmetic is currently the only FDA-approved treatment for lateral canthal lines. In addition to treating canthal lines, Botox is also approved for several intended uses, including temporary improvement of glabellar lines (frown lines), treatment of chronic migraines, severe underarm sweating, blepharospasm (eyelid spasm) and strabismus (misalignment of the eyes).

More information about the FDA drug approval process can be found on the agency’s website. If you have any questions about the drug approval process or compliance with FDA regulations, please contact us at: contact@giannamore-law.com.

FDA Lawyer

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