Sunday, November 19, 2017

What is a therapeutically equivalent drug?


Pharmaceutical Equivalents. Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
  • Pharmaceutical Equivalents
  • Pharmaceutical Alternatives
  • Therapeutic Equivalents 
Orange Book is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.

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Now technology has made it possible for you and me to have an instantaneous answer to the question: “What are the generic equivalents to my brand name drug?” FDA very recently released a mobile app called Orange Book Express, or OB Express. The app is free to download and is available for the iOS and Android platforms.

Thursday, November 16, 2017

Brand Name or Generic Drugs: Your choice


Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.

Generic medicines work the same as brand-name medicines
A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used.

 Generic medicines cost less than brand drugs.
Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness.

If you look up a brand name the references will give you the generic in parenthesis. Also if you look at the label on the bottle it will say under the name generic for and the brand. Of choose if is the brand you won't have that. Labels have a lot of info if people would just read them.

  • Generic name. Each medicine has an approved name called the generic name. A group of medicines that have similar actions often have similar-sounding generic names. For example, ampicillin and flucloxacillin are in one group of antibiotics.
     
  •  Brand name. Many medicines also have one or more brand names. This is chosen by the company that makes it. Several companies may make the same generic medicine, each with their own brand name. For example, paracetamol is a generic name. There are several companies that make this with brand names such as Panadol®, etc.


Medication Price Comparison Features

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