Psycho-Babble Medication Thread 3688

Shown: posts 1 to 6 of 6. This is the beginning of the thread.

 

Reboxetrine

Posted by Mr. Steve on March 14, 1999, at 17:06:58

Does anyone know when this med will be available in the U.S.?

 

Re: Reboxetrine

Posted by Terry on March 14, 1999, at 21:18:06

In reply to Reboxetrine, posted by Mr. Steve on March 14, 1999, at 17:06:58

Mr. Steve -- the last I heard, reboxetine (Edronax)was still being studied in the U.S., but that was in late 1997. At that time, the company said it expected it to be approved in 1999. It's possible it is being reviewed by FDA at this point. Reboxetine is the first of a new class of antidepressants referred to as "selective noradrenaline reuptake inhibitors" (NARIs). It supposedly has fewer side effects than other antidepressants. It is also supposed to be especially effective against severe depression. It's approved in the U.K. and 11 other European countries, so that should help move it along the approval process here. For more information, contact the drug's manufacturer, Pharmacia & Upjohn in NJ. 908-306-4400 or www.pnu.com. They may tell you the status of the drug at the FDA. Terry

> Does anyone know when this med will be available in the U.S.?

 

Re: Reboxetrine

Posted by Mr. Steve on March 14, 1999, at 21:43:40

In reply to Re: Reboxetrine, posted by Terry on March 14, 1999, at 21:18:06

Do you know if this med will be used in conjunction with SSRI's like Celexa?

> Mr. Steve -- the last I heard, reboxetine (Edronax)was still being studied in the U.S., but that was in late 1997. At that time, the company said it expected it to be approved in 1999. It's possible it is being reviewed by FDA at this point. Reboxetine is the first of a new class of antidepressants referred to as "selective noradrenaline reuptake inhibitors" (NARIs). It supposedly has fewer side effects than other antidepressants. It is also supposed to be especially effective against severe depression. It's approved in the U.K. and 11 other European countries, so that should help move it along the approval process here. For more information, contact the drug's manufacturer, Pharmacia & Upjohn in NJ. 908-306-4400 or www.pnu.com. They may tell you the status of the drug at the FDA. Terry
>
> > Does anyone know when this med will be available in the U.S.?

 

Re: Reboxetrine

Posted by Annie on March 15, 1999, at 8:57:54

In reply to Reboxetrine, posted by Mr. Steve on March 14, 1999, at 17:06:58

Psychiatric Times July 1998 Vol. XV Issue 7


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A New Drug Application was submitted to the U.S. Food and Drug Administration in May for the selective norepinephrine reuptake inhibitor (SNRI) antidepressant, reboxetine. The manufacturer, Pharmacia & Upjohn, has marketed the antidepressant as Edronax in the United Kingdom since July 1997, and in October 1997 received approval through the European Mutual Recognition Procedure to distribute it in 11 other European Union Countries during 1998.

> Does anyone know when this med will be available in the U.S.?

 

Re: Reboxetrine

Posted by Terry on March 15, 1999, at 10:49:26

In reply to Re: Reboxetrine, posted by Annie on March 15, 1999, at 8:57:54

Mr. Steve -- There is no way to know definitively when a drug will be approved. Pharmacia & Upjohn and the FDA will not tell you when a drug will be approved once a new drug application has been submitted to the FDA. However, generally, unless there are major problems, drugs are approved within one to two years of an NDA application. In 1997, P&J said they expected the drug to be approved this year (1999), so it's possible it may be approved soon. Terry


> Psychiatric Times July 1998 Vol. XV Issue 7
>
>
> --------------------------------------------------------------------------------
> A New Drug Application was submitted to the U.S. Food and Drug Administration in May for the selective norepinephrine reuptake inhibitor (SNRI) antidepressant, reboxetine. The manufacturer, Pharmacia & Upjohn, has marketed the antidepressant as Edronax in the United Kingdom since July 1997, and in October 1997 received approval through the European Mutual Recognition Procedure to distribute it in 11 other European Union Countries during 1998.
>
>
>
>
>
> > Does anyone know when this med will be available in the U.S.?

 

Re: Reboxetrine

Posted by Emma on May 9, 1999, at 23:29:00

In reply to Re: Reboxetrine, posted by Mr. Steve on March 14, 1999, at 21:43:40

Has anyone heard when this drug will be approved by the FDA?


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