Despite these challenges the generics industry has

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Despite these challenges, the generics industry has adjusted its capabilities in formulations and delivery technologies to open new avenues of opportunity. At the same time, we are seeing the introduction of some new molecules into the r&d department, which has reinvigorated the product lines of many large pharmaceutical companies -- the return of the blockbuster, as they call it. So the future of the generics
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industry looks promising, with big opportunities in all sorts of treatments. Generic Drug Regulations There are already laws regulating generic drugs in America. Before 1962, drugs weren’t approved for effectiveness but only for safety. In 1962, Dr. Francis Kelsey prevented a public health tragedy in the US. The drug thalidomide was being used in many different countries and causing pregnant women to give birth to children with severe birth defects. Dr. Kelsey, who was a medical officer for the FDA, was cautious and ensured that the medicine was never approved and that the product had never been properly tested on pregnant animals before it could be used in America. After this situation, Congress added a requirement for manufacturers to prove their product’s effectiveness before the FDA could approve them for marketing. The Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book ) was created in 1980. It is an FDA published book that lists many drug products and contains indications as to whether generic versions of the medications are considered to be “equivalent” to the drugs made by the innovator company and most marketed under the same name. All states in the U.S. have laws addressing generic substitution to some extent. There are "positive formulary" states, which identify generics that can be substituted, and there are "negative formulary" states, which list drugs that cannot be substituted. There are also states that do not refer to Orange Book standards and have nether a positive nor a negative formulary, and where pharmacists are permitted to perform generic substitution so long as the drugs are pharmaceutically equivalent. (Vivian) In the United States, in order for
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generic drugs to be approved by the FDA they have to meet high standards. The FDA requires drug companies to prove that the generic medicine can be just as effective as the brand-name medicine being copied and provide the same clinical benefit. The drug companies must submit an application, known as an Abbreviated New Drug Application (ANDA), showing the following: The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug. The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical). The inactive ingredients of the generic medicine are acceptable. The generic medicine is manufactured under the same strict standards as the brand-name medicine. The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine's label. (FDA) Hatch-Waxman Act The Hatch-Waxman Act, also known as the Drug Price Competition and Patent
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  • Spring '13
  • Astone
  • Generic drug, Food and Drug Administration, Generic drugs, Drug Price Competition and Patent Term Restoration Act, Abbreviated New Drug Application

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