This request for an extension has been approved by the FDA, giving manufacturers another year to get their NDA applications approved before their drugs become illegal, and leaving these unapproved drugs on the market.
During the period in which Knoll was engaged in their FOIA requests and efforts to bypass the NDA process, Jerome Stevens embarked on the product testing and evaluation procedures needed in order to earn FDA approval for their levothyroxine process.
Their efforts were successful, when on August 22, 2000, the FDA announced that Unithroid had been approved, and was the first and only FDA-approved levothyroxine drug on the market.
When asked whether he was surprised that a small, family-owned company with less than 30 employees earned the first levothyroxine approval, rather than Synthroid's manufacturer, Knoll, which is a division of multi-billion dollar multinational corporation BASF, Steinlauf was philosophical. "Every company was small at one point. And it's encouraging that there is some room for entrepreneurship."
Should You Switch to Unithroid?
Right now, thyroid patients who are taking levothyroxine can choose from the various unapproved brands that have yet to earn approval in the NDA process, or can consider switching to Unithroid.
According to Steinlauf, patients should be aware that some of the unapproved levothyroxine brands on the market have had such fluctuations in active ingredients that make some doses extremely potent versus others. This makes stabilization on a single dosage difficult or impossible for some patients.
"After a ten-year history manufacturing levothyroxine with no product recalls," says Steinlauf, "we had assumed these stability and potency problems were rare. But it seems we didn't realize how good our product was, in comparison to others."
According to the FDA's press release on Unithroid, "the unapproved thyroid hormone replacement products that have been on the market have been associated with stability and potency problems. These problems have resulted in product recalls and have the potential to cause serious health consequences to the public. With the approval of the NDA for Unithroid, patients and physicians now have available to them an oral levothryroxine sodium drug product that has been determined to be safe and effective by the FDA and that also meets FDA standards for manufacturing processes, purity, potency, and stability."
Next week, according to Steinlauf, Jerome Stevens will announce the name of its marketing partner, who will handle setup of the company's patient information line, informational website, and marketing program for distributors and physicians.
Within a month or two, Jerome Stevens' levothyroxine product will be widely available throughout the U.S. under the Unithroid brand name. Until then, physicians and patients need to be aware that the product is already currently available under its previous brandname, "Thyrox." Thyrox/Unithroid are dispensed in the same dosages as Synthroid. Because the potency of the product is guaranteed to fall within a narrow range and remain more stable than the unapproved products, Steinlauf urges patients to be retested about two weeks after switching to his company's product, to ensure that they are receiving the proper dosage.
Steinlauf assures patients that Unithroid will be competitively priced, and, according to Steinlauf, "at a cost less than Synthroid."
References:
- Letter from Dennis Baker to Knoll Pharmaceuticals (FDA website, PDF File)
- FDA Press release on Unithroid
