Genpharm Inc has received the first FDA approval of a generic version of Roche's Accutane. Genpharm's Isotretinoin soft gelatin capsules will be available in 10mg, 20mg, and 40 mg strengths.
Isotretinoin is prescribed for the treatment of severe recalcitrant nodular acne and currently has annual sales in excess of one-half billion dollars in the U.S. market alone. "The FDA's approval affirms that Genpharm's Isotretinoin is AB-rated and bioequivalent to Roche's Accutane capsules. This coupled with President Bush's pro-generic stance and the FDA's strong public endorsements of generic medicines, makes Genpharm's Isotretinoin an excellent alternative to the high cost branded product", says Hank Klakurka, C.E.O., Genpharm.
Exclusive marketing rights have been awarded to Mylan Laboratories' unit, Bertek Pharmaceuticals. Bertek will be responsible for all sales and marketing activities of the product under the brand name Amnesteem. The Oral Technologies unit of Cardinal Health Inc will handle all manufacturing & packaging activities for the product. Product Launch is expected to be within days.
Genpharm Inc is engaged in the development, manufacturing and marketing of high quality, cost effective prescription medicines throughout the world. Genpharm and it's Merck Generic Group of companies today hold approvals for 36 pharmaceutical products and four tentative approvals in the United States with many more in the process of review by the FDA.