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U.S. Department of Health and Human Services

Safety

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Gabitril (tiagabine HCl) Dear Healthcare Professional Letter Aug 2001

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

 


This is the retyped text of a letter from Cephalon, Inc. Contact the company for a copy of any referenced enclosures.


Dear Healthcare Professional:

This letter is in reference to changes to the product name of GABITRIL (tiagabine HCl) Tablets.

This letter serves to notify healthcare professionals that Cephalon, Inc. is removing the word Filmtabâ from the GABITRIL product name. This is a result of the acquisition of GABITRIL by Cephalon from Abbott Laboratories, since the word Filmtab is a registered trademark of Abbott Laboratories. The change in the GABITRIL product name will be reflected in all related documents (e.g., prescribing information, and packaging material).

Please note that this change pertains only to the product name of GABITRIL. The formulation and manufacturing process of GABITRIL Tablets has not changed. All prescribing physicians and dispensing pharmacists can be confident that the integrity of GABITRIL Tablets is not affected by this change in any way.

Please note that the appearance of GABITRIL Tablets has been changed to replace the Abbott logo with the Cephalon logo. GABITRIL Tablets also have new National Drug Code (NDC) numbers for each tablet strength, which reflect Cephalon's ownership of the product.

We hope this information is helpful. If you have additional questions please feel free to contact Cephalon Professional Services at (800) 896-5855.

Sincerely,

 

Kiumars Vadiei, Ph.D., R.Ph., F.C.P.
Director, Professional Services/Medical Information