Psycho-Babble Medication Thread 599003

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Nardil (phenelzine) information

Posted by sdb on January 14, 2006, at 9:30:48

Concord (uk) has no plans to discontinue Nardil (phenelzine). It is officially sold in Belgium and Australia. Pfizer retain the rights for phenelzine in the US. The "molecule" phenelzine of Pfizer and Concord is the same but not the formula.

 

ACE the Nardil champ takes the UK Nardil?

Posted by ed_uk on January 14, 2006, at 13:02:18

In reply to Nardil (phenelzine) information, posted by sdb on January 14, 2006, at 9:30:48

Just to clarify :)

Sdb emailed Concord Pharmaceuticals - who supply Nardil to the UK market on behalf of Link Pharmaceuticals, who hold the product license.

Some important points.........

1. They have no plans to discontinue Nardil in the UK.

2. The UK brand of Nardil contains different 'inactive ingredients' to the US brand.

3. The UK Nardil is exported to Belgium (where it is sold as Nardelzine) and Australia.

Presumably, ACE the Nardil champ (who lives in Australia) takes the UK Nardil.

Ed

 

Re: Nardil (phenelzine) information » sdb

Posted by Tomatheus on January 14, 2006, at 15:27:10

In reply to Nardil (phenelzine) information, posted by sdb on January 14, 2006, at 9:30:48

> The "molecule" phenelzine of Pfizer and Concord is the same but not the formula.

sdb,

That's exactly right. In terms of their inactive ingredients, the "old" Pfizer Nardil, the "new" Pfizer Nardil, the U.K. Concord Nardil, and the Australian Link Nardil are all different from one another.

For a breakdown of the excipients of the four Nardil formulations mentioned above, I'm going to paste the text of an e-mail that I recently sent to a Yahoo! group on MAOIs.

Tomatheus

==

And here's a copy of the information from my e-mail...

THE "OLD" PFIZER NARDIL (Parke-Davis Division of Pfizer Inc., 2001)
* Acacia, NF
* Calcium carbonate
* Carnauba wax, NF
* Corn-starch, NF
* FD and C yellow No. 6
* Gelatin, NF
* Kaolin, USP
* Magnesium stearate, NF
* Mannitol, USP
* Pharmaceutical glaze, NF
* Povidone, USP
* Sucrose, NF
* Talc, USP
* White wax, NF
* White wheat flower

THE "NEW" PFIZER NARDIL (Parke-Davis Division of Pfizer Inc., 2003)
* Mannitol, USP
* Croscarmellose sodium, NF
* Povidone, USP
* Edetate disodium, USP
* Magnesium stearate, NF
* Isopropyl alcohol, USP
* Purified water, USP
* Opadry orange Y30-13242A
* Simethicone emulsion, USP

Note: The labeling document that Pfizer submitted to the FDA as part of its supplemental new drug application (dated March 27, 2003) listed "corn starch, NF" as an inactive ingredient using strikethrough formatting.

CONCORD (U.K.) NARDIL (James, 2006)
* Mannitol
* Povidone
* Magnesium stearate and maize starch with the tablet coating containing hydroxypropyl cellulose
* Polyvinylacetatephthalate
* Stearic acid
* Sunset yellow (E110)
* Titanium dioxide (E171)
* Erythrosine (E127)
* Hydroxypropylmethylcellulose (E464)
* Talc

According to David James (2006), Concord's product information and technology executive, the company's formulation "has been in use prior to the current Marketing Authorisation Holder acquiring the rights to the product in 1999."

LINK (AUSTRALIA) NARDIL (Link Medical Products Pty Ltd, 2004)
* Mannitol
* Povidone
* Maize starch
* Magnesium stearate
* Coating (Opadry 20A25096 Red)

==

REFERENCES

James, D., personal communication (e-mail), Jan. 4, 2006.

Link Medical Products Pty Ltd. (2004). Nardil Phenelzine Consumer Medical Information. (Available from Link Pharmaceuticals Pty Ltd; Level 1, Bridgeport Centre; 3 Brady St.; Mosman NSW 2088, Australia)

Parke-Davis Division of Pfizer Inc. (2003). Nardil® (Phenelzine Sulfate Tablets, USP), labeling information. Retrieved January 13, 2006, from http://www.fda.gov/cder/foi/label/2003/11909slr033_nardil_lbl.pdf

Parke-Davis Division of Pfizer Inc. (2001). Nardil® (Phenelzine Sulfate Tablets, USP), labeling information. Retrieved January 13, 2006, from http://www.fda.gov/cder/foi/label/2002/11909slr030lbl.pdf

 

Re: Nardil (phenelzine) information » Tomatheus

Posted by ed_uk on January 15, 2006, at 9:41:48

In reply to Re: Nardil (phenelzine) information » sdb, posted by Tomatheus on January 14, 2006, at 15:27:10

Hi

Are you sure that the Australian Nardil is different to the UK Nardil?

Concord said that their product is exported to Australia.

Remember that Concord supply UK Nardil on behalf of Link, who hold the product license. The UK Nardil *is* the Link Nardil.

Many of the (extra) ingredients you listed under the UK Nardil will be present in the 'coating' of Australian Nardil.

Ed

 

Re: Nardil (phenelzine) information » ed_uk

Posted by Tomatheus on January 15, 2006, at 10:17:36

In reply to Re: Nardil (phenelzine) information » Tomatheus, posted by ed_uk on January 15, 2006, at 9:41:48

Ed,

You're always keeping me on my toes.

The inactive ingredients for the Concord U.K. Nardil and the Link Australian Nardil are clearly listed differently, but now I see that it's probably the case that the "coating" ingredient listed in Link's Nardil likely includes some -- if not all -- of the ingredients that are listed in Concord's Nardil but not Link's. So, considering that Concord holds Link's product license, I'd have to say that you're right about the two Nardils being the same; it's just that the inactive ingredients happened to be listed differently.

I apologize for my misleading conclusion. The facts in my lists were correct, but just listed in different ways, and I didn't interpret them correctly in my opening statements.

Tomatheus

 

Re: Nardil (phenelzine) information » Tomatheus

Posted by ed_uk on January 15, 2006, at 11:35:28

In reply to Re: Nardil (phenelzine) information » ed_uk, posted by Tomatheus on January 15, 2006, at 10:17:36

Hi T

>I apologize for my misleading conclusion.

I'm not saying you're wrong, just that you might be :)

Ed

 

Re: Nardil (phenelzine) information ed_uk (nm)

Posted by sdb on January 16, 2006, at 16:33:10

In reply to Re: Nardil (phenelzine) information » Tomatheus, posted by ed_uk on January 15, 2006, at 11:35:28

Thanks ed for clarification.


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