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About Michael Anisfeld
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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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You are here:  Experts > Health/Fitness > Pharmacology > Pharmaceuticals > generic vs brand med

Pharmaceuticals - generic vs brand med


Expert: Michael Anisfeld - 5/12/2004

Question
Hello,

Hope I'm in the right dept. with my question, here goes:
I'm 59, female... diagnosis= hypothyroidism. Was taking Synnthroid/ then levoxyl/levothyroxine for years, symptoms persist.  So did some reading about Armour Thyroid...asked dr to switch my prescription and he did.
My question is about the stability of the generic version of Armour Thyroid. It's available and cheaper so I'd like to be conservative and buy it.(dr doesn't have any opinion)
The pharmacist told me it wouldn't be as "pure" as the brand and I'm skeptical.

In the past I've used generic meds and had good results.

If the standards and regulations are the same for manufacture of generics as for brand.......why should I have to worry about generics being more unstable than brand?

Can you give me any info....I haven't been able to find any web info re: research or studies etc.

I'm thanking you in advance for your help and comments.
ajc

Answer
Regretfully your pharmacist might be an expert on the actions of drugs but he/she knows very little about drug formulation and drug development.

A generic drug manufacturer must provide scientific evidence to FDA that the generic version is equivalent in purity, strength, bioavailability and stability as the originator drug (The "Armour Thyroid"), prior to gaining approval to market the product.

I am an industrial pharmacist and very involved with drug quality, and drug registration at the manufacturing stage.
I have no personal qualms at all about taking any generic version of any drug as long as it was made in the USA by a company regsitered with FDA.

For a list of FDA approved generic brands check out FDA's website at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

and enter the drug's generic name LEVOTHYROXINE SODIUM and you will find details of 7 generic manufacturers and the originator (8 entries in total). Click on anyone to find details of who they are.

I hope this helps,
Michael Anisfeld

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