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FDA Approves Botox Cosmetic for Lines, Wrinkles

Allergan news release; 2017 Oct 3

Allergan plc has announced the FDA approval of Botox Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for 3 facial treatment areas: forehead lines, crow's feet lines, and glabellar lines.

Indications: Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of:

  • Moderate to severe glabellar lines associated with corrugator and/orprocerus muscle activity.
  • Moderate to severe lateral canthal lines associated with orbicularis oculiactivity.
  • Moderate to severe forehead lines associated with frontalis muscle activity,

Dosage/administration: Botox Cosmetic is administered by intramuscular injection and patients should follow dosage and administration recommendations (https://www.allergan.com/assets/pdf/botox_cosmetic_pi). Adults being treated for >1 approved indication with Botox and Botox Cosmetic should not exceed a total dose of 400 units administered in a 3-month interval.

Adverse effects: The most common adverse reactions are:

  • Glabellar lines: eyelid ptosis (3%).
  • Lateral canthal lines: eyelid edema (1%).
  • Forehead lines: headache (9%) and brow ptosis (2%).

Citation:

FDA approves BOTOX® Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. [news release]. Dublin, Ireland: Allergan plc. October 3, 2017. https://www.allergan.com/News/News/Thomson-Reuters/FDA-Approves-BOTOX-Cosmetic-OnabotulinumtoxinA-for. Accessed October 18, 2017.