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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
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