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Article: Barr Receives Tentative Approval for Mirtazapine Orally Disintegrating Tablets, 45 mg.
- Article from:
- PR Newswire
- Article date:
- January 7, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Organon, Inc.'s Remeron(R) Soltab(TM) Orally Disintegrating Tablets, 45 mg (Mirtazapine Orally Disintegrating Tablets). The Company anticipates receiving final approval for its generic product following the expiration of certain exclusivities surrounding this product.
Mirtazapine Orally Disintegrating Tablets are indicated for the treatment of depression. Remeron Soltabs, 45 mg had annual sales of approximately $17 million for the twelve months ended November 2004, ...