|
|
Article: Mayne Pharma (USA), Inc., Paramus, NJ, Feb. 1 (DDMAC).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
- Article from:
- Warning Letter Bulletin
- Article date:
- March 1, 2006
CopyrightCOPYRIGHT 2006 Washington Information Source, Inc. 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)
|
FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) reviewed a promotional mailer for the company's M.V.I.-12 (multivitamin infusion without vitamin K) submitted by Mayne Pharma (USA) and found the mailer misleading because it omitted important risk information and because it suggested that M.V.I.-12 was safer than has been demonstrated by substantial evidence or clinical experience.
According to the PI, the M.V.I.-12 formulation is indicated for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition who also receive warfarintype anticoagulant therapy. Physicians are warned not to ...