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U.S. Department of Health and Human Services

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Lithobid (lithium carbonate) Dear Healthcare Professional Letter Nov 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 Solvay Pharmaceuticals. Contact the company for a copy of any referenced enclosures.


Re: 18 Month Expiration Dating for LITHOBID (lithium carbonate)
Slow-Release Tablets


Dear Healthcare Professional:


Last August, Solvay Pharmaceuticals, Inc. informed you of our need to find a new source of raw
material, lithium carbonate, for LITHOBID Slow-Release Tablets. This need resulted in a
temporary reduction in the product's expiration dating. Since then, Solvay Pharmaceuticals has
generated additional stability information for LITHOBID Slow Release Tablets to extend the
expiration date.


Solvay Pharmaceuticals would like to advise you of an increase in the expiration dating (or
shelf life) for LITHOBID Slow Release Tablets to 18 months, as approved by the Food and
Drug Administration (FDA).


The recommendations previously made to prescribe and dispense 30-day quantities of
LITHOBID Slow Release Tablets are no longer relevant. Physicians and pharmacists may
prescribe and fill prescriptions in their usual and customary manner.


Solvay Pharmaceuticals appreciates, and wishes to acknowledge, the close cooperative working
relationship with the FDA that has allowed us to maintain adequate supplies of this medically
important product.


Please see full prescribing information enclosed.


If you have any questions, please call Solvay Pharmaceuticals' Customer Service line at
1-800-241-1643; press option 6 and then option 5.


Best Regards,


Harold H. Shlevin, Ph.D.
President & Chief Executive Officer

Solvay Pharmaceuticals, Inc.
901 Sawyer Road
Marietta, GA 30062
Phone: 770.578.5740
Solvay Pharmaceuticals