New Generic Drugs
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s research and development by giving the company that develops it the right to be the only company that sells the drug while the patent is still in effect.
When the patents right period of exclusivity expire, manufacturers admit an application to the Federal Drug Administration to sell generic versions of a particular brand name drug. The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness when the brand name drug was approved. This applies only to drugs first marketed after 1962.
Health professionals and consumers must make sure that the generic version on the shelvs in their corner storesare FDA approved. this will be mentioned on the container the drug is in. Once they customers see the federal Drug Administratiions seal on the box they can be assured that iut is an FDA approved generic drugs and that it met the same rigid standards as the name brand drug. In order for a generic to gain FDA approval, a generic drug must:
a) contain the same active ingredients as the innovator drug (inactive ingredients may vary)
b) be identical in strength, dosage form, and route of administration
c) have the same use indications
d) be bioequivalent
e) meet the same batch requirements for identity, strength, purity, and quality
F) be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products.