FDA confirms reasons for Accutane withdrawal to Sun
This article was originally published in Scrip
In response to a citizen petition filed by Sun Pharmaceutical, the US FDA has reviewed its records and determined that Roche's branded product, Accutane (isotretinoin), was not withdrawn from sale for reasons of safety or effectiveness, according to a Federal Register notice. Thus, the agency will continue to allow generic isotretinoin products to be marketed; the product was approved for severe acne treatment and first became available back in 1982.
Roche stated last year that it was discontinuing the marketing of Accutane capsules (scripintelligence.com, 30 June 2009). At that time, Roche had cited business reasons arising from generic competition, saying that its market share had declined steadily to below 5% and the drug had high costs from personal injury lawsuits.
After indicating that the petitioner, Sun, had identified no data or other information suggesting that the branded product had been withdrawn for reasons of safety or effectiveness, the regulator stated: "FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list Accutane (isotretinoin) Capsules, 10mg, 20mg and 40mg in the Discontinued Drug Product List section of the Orange Book. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to Accutane." (New ANDAs will refer to a listed product other than the brand product.)
Accutane has been available as a generic since 2002, with versions manufactured or distributed by Barr (part of Teva), GenPharm/Mylan and Ranbaxy Laboratories.
Personal injury lawyers have been claiming that the product is linked to a number of serious side-effects, including Crohn's disease, inflammatory bowel disease and ulcerative colitis.