Thursday, August 02, 2001 08:00 IST A Correspondent, Illinois
Abbott Laboratories has submitted a New Drug Application (NDA) for Synthroid (levothyroxine sodium, USP) to the U.S. Food and Drug Administration (FDA), nearly two weeks in advance of the FDA's deadline of August 14.
"The submission of this NDA is an important milestone in Abbott's continuing commitment to the millions of thyroid patients who rely on Synthroid," said Jeffrey Leiden, Abbott's chief scientific officer and executive vice president, Global Pharmaceuticals. "Since learning from the FDA in April - a month after we acquired the previous manufacturer of Synthroid - that a formal NDA for Synthroid would be required, Abbott has been hard at work compiling the extensive data necessary for the agency's review," Dr. Leiden said.
In its July 12, 2001 guidance, the FDA allowed Synthroid to remain on the market subject to a gradual phase down of distribution while the agency reviews the NDA Abbott has submitted for this product.
In 1997, the FDA announced that every manufacturer of levothyroxine sodium products, most of which had been on the market for many years, would be required as part of the agency's regulatory process to file either an NDA, or submit a citizen petition showing that their products are not new drugs and therefore do not require an NDA.
The manufacturer of Synthroid at the time, Knoll Pharmaceutical Company, which Abbott acquired in March 2001, exercised the citizen petition option because of the heritage of clinical experience of Synthroid. On April 26, the FDA denied Knoll's petition. Abbott promptly responded to the FDA that the company would submit an NDA for Synthroid.
Synthroid is indicated for the treatment of hypothyroidism. Thyroid hormones, either alone or together with other medicines, should not be used for the treatment of obesity, and should not be taken by patients with untreated thyrotoxicosis (excess of thyroid hormone), uncorrected adrenal insufficiency, or apparent hypersensitivity to thyroid hormones or any inactive product constituents.
