This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryNDA for thyroid hormone is submitted Aug. 1, two weeks prior to FDA's Aug. 14 deadline for approved applications for oral levothyroxine products. Abbott said that "all patients can be assured of continued access to Synthroid," since there are sufficient supplies of the drug in the marketplace. FDA specified that there be a gradual phase-down of distribution until the NDA is approved
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