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Ortho McNeil Neurologics
April 28, 2005 The purpose of this letter is to inform you of two important developments pertaining to REMINYL (galantamine HBr), a medication indicated for mild to moderate dementia o the Alzheimer's type: -REMINYL is being renamed RAZADYNE (galantamine HBr) - A once daily formulation of RAZADYNE (formerly REMINYL), RAZADYNE ER (galantamine HBr), will be available soon. REMINYL Brand Name Changed to RAZADYNE to Help Avoid Potential Errors in Filling Prescriptions To foster safe medication prescribing and dispensing, Ortho-McNeil Neurologics, Inc., decided to change the brand name REMINYL to avoid confusion with the diabetes drug Amaryl (glimepiride). Ortho-McNeil Neurologics, Inc., began working closely with the US Food and Drug Administration last fall after learning of several reports of errors in prescribing and dispensing due to confusion between the two medications. We are committed to patient safety, and the name change is a reflection and a result of this commitment. REMINYL and RAZADYNE are exactly the same medication-galantamine HBr. Only the brand name and the NDC numbers are changing. RAZADYNE is exactly the same as REMINYL in all other respects, including ingredients, dosage forms and strengths, appearance, and price. Because they are the same medication, pharmacists can fill REMINYL prescriptions with REMINYL or RAZADYNE without consulting with or calling a physician. We request that pharmacists and wholesalers please continue to use their current inventory of REMINYL when filling prescriptions. Prescriptions for RAZADYNE may be filled with REMINYL and prescriptions for REMINYL may be filled with RAZADYNE. Please also note that because they are the same medication, patients should not take RAZADYNE and REMINYL at the same time. I am also pleased to announce that RAZADYNE ER, the once-daily formulation of RAZADYNE, will be available soon. Thank you for your attention and for your support of all Ortho-McNeil Neurologics, Inc. products. If you have any medical questions, please call 1-800-526-7736. Please see important safety information on reverse side. Please also see the enclosed full prescribing information. Respectfully, Joseph Hulihan, MD Vice President, Medical Affairs Ortho-McNeil Neurologics, Inc. |
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