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Abbott Files New Drug Application for Synthroid |
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Drug Likely to Remain Available During Approval Process
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by Mary J. Shomon
August 1, 2001 --
On August 1, 2001, Abbott Laboratories announced that it has finally filed with the Food and Drug Administration (FDA) a new drug application (NDA) for Synthroid.
The NDA was filed two weeks before the August 14, 2001 final deadline for Synthroid's application to be submitted, putting to an end the speculation that Synthroid might not submit in time, and face withdrawal from the market.
Synthroid will now be able to remain on the market, although following the FDA's phase-out production schedule, until approval is granted, at which point full distribution will again be available.
Levothyroxine approval has been running nine to ten months, so FDA approval is expected no later than summer 2002.
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