Know About Orange Book

The "Approved Drugs With Therapeutic Equivalency Rating" (a list known as the "Orange Book") identifies drugs approved by the Food and Drug Administration (FDA) of the Federal Food, Drug Administration and Law on the basis of safety and efficacy for cosmetics (FD&C Act).

If you want to see the list of drugs in orange book, then you may hop over here.

The main criterion for submitting a product is that it is the subject of an application for approval that has not been withdrawn for safety or efficacy reasons. Inclusion of a product in the Orange Book does not depend on current legal or legal action against a drug.

Additionally, the Orange Book includes an evaluation of the therapeutic equivalence of approved prescription drugs from multiple sources.

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These evaluations serve as public information and advice to public health authorities, prescribing authorities and pharmacists to promote public education about drug selection and health care cost reduction.

To limit drug costs, nearly every state has laws and / or regulations that encourage drug replacement. These state laws usually require that substitution be restricted to drugs on a certain list (positive approach) or to be permitted for all drugs except those exempted from a certain list (negative approach).

With many requests in the late 1970s for FDA assistance to develop positive and negative formulas, it became clear that the FDA could not serve the needs of each country individually. The agency also recognizes that providing one list based on general criteria is preferable to evaluating drugs based on different definitions and criteria in different national legislation.

Consequently, on May 31, 1978, the Commissioner for the Food and Drug Administration sent a letter to officials in each state announcing the FDA's intention to provide a list of all FDA-approved prescription drugs. Efficacy along with determining therapeutic equivalents for multi-oral prescription products.