Lithobid (lithium carbonate) Dear Healthcare Professional Letter Nov 2001
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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)
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
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
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.
Harold H. Shlevin, Ph.D.
President & Chief Executive Officer
901 Sawyer Road
Marietta, GA 30062