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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (4310)	7/14/2001 12:23:46 AM
From: Doc Bones	Read Replies (1) \| Respond to of 52153

"We're doing our bit to keep America drug-free!" They "just say no," don't they?

To: Biomaven who wrote (4310)	7/14/2001 2:09:27 AM
From: Doc Bones	Read Replies (1) \| Respond to of 52153

"Another hormone, Synthroid, also put up a huge fight against generics." A quote from Peter, post #1970 Synthroid's got another fight now, with those guys at the FDA, who just sent me an e-mail: Alright punk, because of you and wiseass Suzman (post #4310), we're not only not going to approve any new drugs, we're gonna go back and disapprove all the ones people are already taking. Where's your test data on aspirin, huh? OK, I made that up, but I didn't make this up: July 13, 2001 nytimes.com Abbott Told to Reduce Supply of Unapproved Thyroid Drug By MELODY PETERSEN The Food and Drug Administration said yesterday that Abbott Laboratories must gradually reduce its distribution of a highly prescribed thyroid drug while it applies for regulatory approval of the medication. The drug, Synthroid, which is taken by patients with thyroid disorders, was the third-most-prescribed drug in the United States last year, with sales exceeding $400 million. It has been sold in the United States since 1955. The F.D.A. said that there was no public health emergency that required patients to immediately switch to other drugs. Instead, the agency said it wanted to give patients time to switch from Synthroid and other similar drugs in its class that have never received federal approval to the two thyroid medications that have been approved. Those are Unithroid, sold by Watson Pharmaceuticals (news/quote) and Jerome Stevens Pharmaceuticals, and Levoxyl, sold by King Pharmaceuticals (news/quote). Abbott said yesterday that it was confident that Synthroid was safe and that it planned to file studies with the F.D.A. that proved so in the next few weeks. The F.D.A. said yesterday that Abbott had until Aug. 14 to file the studies and other information required to gain federal approval of Synthroid. The company must immediately stop distributing Synthroid if it misses the deadline, the agency said. But even if Abbott files the information, the company will have to gradually cut its distribution while it waits for the F.D.A.'s decision, the agency said. The shipments must be cut by 5 percent by November, 10 percent by February and 20 percent by May, the agency said. The reductions would continue until all distribution ceased in August 2003. If the F.D.A. approves Synthroid after reviewing Abbott's studies, the company would no longer have to limit the drug's shipments. The company said it was concerned that gradually reducing distribution would cause many patients to unnecessarily switch to other products that it said were not therapeutically equivalent to Synthroid. The F.D.A. said yesterday it did not know why Synthroid and other similar drugs were not approved decades ago. In 1997, the F.D.A. told manufacturers of the drugs that they would have to submit new drug applications that proved their safety and effectiveness. There had been numerous recalls of the thyroid medications, and the agency was increasingly concerned about problems with the their stability and potency. At the time, Synthroid was sold by the Knoll (news/quote) Pharmaceutical Company. Abbott acquired Knoll in March. A month later the F.D.A. denied a petition that Knoll had filed claiming that the drug was safe. Abbott then told the agency that it would soon file the more detailed application and studies to prove Synthroid's safety. The company said the F.D.A.'s decision would have no impact on its earnings this year. It also reported its results for the second quarter, saying its net income fell 23 percent because of a charge related to the Knoll acquisition. Net income fell to $529 million, or 34 cents a share, from $685 million, or 44 cents a year earlier.