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Accutane (isotretinoin)

Roche's brand of isotretinoin, approved in 1982 for severe nodular acne and discontinued in the U.S. in 2009.

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  1. 1982 Hoffmann-La Roche launched Accutane (isotretinoin)
Proof 3 sources
  1. Determination That ACCUTANE (Isotretinoin) Capsules, 10 Milligrams, 20 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register), U.S. Food and Drug Administration, 7 Jul 2010. Primary record
    ACCUTANE (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg, are the subject of NDA 18-662, held by Hoffman-La Roche, Inc. (Roche), and initially approved on May 7, 1982.
  2. Roche loses lawsuit over side effects of acne drug Accutane, PharmaTimes. Scholarship & press
    Roche has suffered a legal setback with the news that a jury in New Jersey declared that the Swiss company did not warn a plaintiff in the first of 400 lawsuits that its Accutane acne drug can cause inflammatory bowel disease.
  3. Questions and Answers on the iPLEDGE REMS (FDA, content current as of 16 Jun 2026), U.S. Food and Drug Administration. Primary record
    Isotretinoin can cause serious side effects, including birth defects. Because of the risk of severe birth defects, isotretinoin has only been available through a restricted distribution program called the iPLEDGE Program since 2005 and approved as the iPLEDGE REMS in 2010.
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