FDA News

FDA approves Botox for forehead lines

Allergan announced today that the FDA has approved Botox Cosmetic for the temporary improvement of the appearance of forehead lines associated with frontalis muscle activity in adults, according to a company press release.

Botox is the first and only neurotoxin injection medicine approved by the FDA for forehead lines, crow’s feet lines and glabellar lines, according to the release.

In 2002, Botox Cosmetic received its first FDA approval for the temporary improvement in the appearance of moderate to severe glabellar lines, and in 2013 the treatment was approved for the temporary improvement in the appearance of moderate to severe crow’s feet lines.

In clinical trials, Botox demonstrated superiority over placebo at reducing the severity of forehead lines at 30 days: 61% of patients who received Botox vs. 0% of patients who received placebo in one trial, and 46% of patients who received Botox vs. 1% of those who received placebo in a second study, according to the release.

"As a physician, I've been using Botox Cosmetic since it was FDA approved in 2002, but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead," Steven Fagien, MD, an oculoplastic surgeon in Boca Raton, Florida, and lead clinical trial investigator, said in the release.

Disclosures: Healio Aesthetics was unable to confirm any relevant financial disclosures at the time of publication.

Allergan announced today that the FDA has approved Botox Cosmetic for the temporary improvement of the appearance of forehead lines associated with frontalis muscle activity in adults, according to a company press release.

Botox is the first and only neurotoxin injection medicine approved by the FDA for forehead lines, crow’s feet lines and glabellar lines, according to the release.

In 2002, Botox Cosmetic received its first FDA approval for the temporary improvement in the appearance of moderate to severe glabellar lines, and in 2013 the treatment was approved for the temporary improvement in the appearance of moderate to severe crow’s feet lines.

In clinical trials, Botox demonstrated superiority over placebo at reducing the severity of forehead lines at 30 days: 61% of patients who received Botox vs. 0% of patients who received placebo in one trial, and 46% of patients who received Botox vs. 1% of those who received placebo in a second study, according to the release.

"As a physician, I've been using Botox Cosmetic since it was FDA approved in 2002, but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead," Steven Fagien, MD, an oculoplastic surgeon in Boca Raton, Florida, and lead clinical trial investigator, said in the release.

Disclosures: Healio Aesthetics was unable to confirm any relevant financial disclosures at the time of publication.