Fw: FDA Will Not Yet Withdraw Unapproved Thyroid Drug

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Friday, July 13, 2001 12:20 AM

Subject: FDA Will Not Yet Withdraw Unapproved Thyroid Drug

> FDA Will Not Yet Withdraw Unapproved Thyroid Drug (Reuters)

>>

http://rd./alerts/email/news/*http://dailynews./h/nm/20010

712/

> hl/fda_1.html

>

> Thursday July 12 1:19 PM ET

>

> FDA Will Not Yet Withdraw Unapproved Thyroid Drug

>

> WASHINGTON (Reuters Health) - In a move partially meant to allay the fears

> of the millions of Americans taking Synthroid, the US Food and Drug

> Administration (FDA) clarified on Thursday that the agency has given

makers

> of the thyroid drug until August 14 to file for approval.

>

> The FDA also said that it does not intend to immediately withdraw any

> unapproved levothyroxine products currently on the US market, citing the

> concern that it will take considerable time for patients on the unapproved

> products to switch to approved ones.

>

> Used by millions of Americans for the treatment of thyroid disease,

> levothyroxine has been available on the US market for many years without

> FDA approval. Synthroid is the most commonly prescribed levothyroxine

> product and the nation's third mostly commonly prescribed medication. It

> has been on the US market for about 40 years without FDA approval.

>

> The FDA said that it would phase out the unapproved products over a 2-year

> period if they fail to file for approval by the August deadline or their

> approval application is denied. In 1997, the FDA announced that every

> manufacturer of levothyroxine would be required to either file a new drug

> application (NDA) and/or citizen petition showing that their products are

> not new drugs. The agency said that it was issuing the rule because it

> determined that levothyroxine itself could not be generally recognized as

a

> safe and effective treatment.

>

> Although the FDA has since approved two orally administered levothyroxine

> products, that announcement recently has created considerable difficulty

> for the agency because of media reports suggesting that the FDA might

> withdraw Abbott Laboratories' thyroid drug Synthroid, which Abbott

acquired

> in March as a result of its merger with Knoll Pharmaceutical Company.

>

> The media reports were based upon the fact that Knoll Pharmaceutical

> Company had failed to file an NDA, choosing instead to file a citizen's

> petition that the FDA subsequently denied in April.

>

> The Abbott Park, Illinois-based drug manufacturer issued immediate praise

> for the FDA clarification.

>

> ``If their medication is switched, patients must be reevaluated and

> re-tested,'' noted Dr. Pizzuti, Abbott's vice president for global

> medical affairs.

>

> Abbott further confirmed that it plans to file an NDA by the agency's

> August deadline. ``Abbott is confident that the Synthroid NDA will

> demonstrate safety and efficacy and will be approved,'' Pizzuti said.

>

> But the consumer group Gray Panthers, while praising the FDA

clarification,

> offered a different interpretation of the FDA's guidance. According to the

> group, which has in the past expressed concerns about Synthroid's safety,

> the FDA guidance means that Abbott would need to reduce its sales of

> Synthroid by 55% within a year and terminate sales completely within 2

> years.

>

> The group acknowledged that Abbott could resume sales of the product if

the

> company was able ``to demonstrate that Synthroid is stable and of

> consistent potency.''

>

> The approved levothyroxine products currently include

> Pharmaceuticals Inc.'s Unithroid and King Pharmaceuticals Inc.'s Levoxyl.

>

>

>

>

>

[Guest guest]

This blows my mind!! I have been a nurse for 9 yrs and

never knew that Synthroid was not FDA approved!!

Unbelievable. And it's even in all the drug books and

was in my pharmacology book as a nursing student. Wow!!

e

> From: " ilena rose " <ilena@...>

> Sent: Friday, July 13, 2001 12:20 AM

> Subject: FDA Will Not Yet Withdraw Unapproved Thyroid Drug

>

>

> > FDA Will Not Yet Withdraw Unapproved Thyroid Drug (Reuters)

> >>

> http://rd./alerts/email/news/*http://dailynews./h/nm/20010

> 712/

> > hl/fda_1.html

> >

> > Thursday July 12 1:19 PM ET

> >

> > FDA Will Not Yet Withdraw Unapproved Thyroid Drug

> >

> > WASHINGTON (Reuters Health) - In a move partially meant to allay the fears

> > of the millions of Americans taking Synthroid, the US Food and Drug

> > Administration (FDA) clarified on Thursday that the agency has given

> makers

> > of the thyroid drug until August 14 to file for approval.

> >

> > The FDA also said that it does not intend to immediately withdraw any

> > unapproved levothyroxine products currently on the US market, citing the

> > concern that it will take considerable time for patients on the unapproved

> > products to switch to approved ones.

> >

> > Used by millions of Americans for the treatment of thyroid disease,

> > levothyroxine has been available on the US market for many years without

> > FDA approval. Synthroid is the most commonly prescribed levothyroxine

> > product and the nation's third mostly commonly prescribed medication. It

> > has been on the US market for about 40 years without FDA approval.

> >

> > The FDA said that it would phase out the unapproved products over a 2-year

> > period if they fail to file for approval by the August deadline or their

> > approval application is denied. In 1997, the FDA announced that every

> > manufacturer of levothyroxine would be required to either file a new drug

> > application (NDA) and/or citizen petition showing that their products are

> > not new drugs. The agency said that it was issuing the rule because it

> > determined that levothyroxine itself could not be generally recognized as

> a

> > safe and effective treatment.

> >

> > Although the FDA has since approved two orally administered levothyroxine

> > products, that announcement recently has created considerable difficulty

> > for the agency because of media reports suggesting that the FDA might

> > withdraw Abbott Laboratories' thyroid drug Synthroid, which Abbott

> acquired

> > in March as a result of its merger with Knoll Pharmaceutical Company.

> >

> > The media reports were based upon the fact that Knoll Pharmaceutical

> > Company had failed to file an NDA, choosing instead to file a citizen's

> > petition that the FDA subsequently denied in April.

> >

> > The Abbott Park, Illinois-based drug manufacturer issued immediate praise

> > for the FDA clarification.

> >

> > ``If their medication is switched, patients must be reevaluated and

> > re-tested,'' noted Dr. Pizzuti, Abbott's vice president for global

> > medical affairs.

> >

> > Abbott further confirmed that it plans to file an NDA by the agency's

> > August deadline. ``Abbott is confident that the Synthroid NDA will

> > demonstrate safety and efficacy and will be approved,'' Pizzuti said.

> >

> > But the consumer group Gray Panthers, while praising the FDA

> clarification,

> > offered a different interpretation of the FDA's guidance. According to the

> > group, which has in the past expressed concerns about Synthroid's safety,

> > the FDA guidance means that Abbott would need to reduce its sales of

> > Synthroid by 55% within a year and terminate sales completely within 2

> > years.

> >

> > The group acknowledged that Abbott could resume sales of the product if

> the

> > company was able ``to demonstrate that Synthroid is stable and of

> > consistent potency.''

> >

> > The approved levothyroxine products currently include

> > Pharmaceuticals Inc.'s Unithroid and King Pharmaceuticals Inc.'s Levoxyl.

> >

> >

> >

> >

> >

>

>

>