Search results
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Generic drug applications are termed "abbreviated" because (in comparison with a New Drug Application ) they are generally not required to include preclinical (animal and in vitro) and clinical ...
e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate ...
Ciprofloxacin is a broad-spectrum antibiotic of the fluoroquinolone class. It is active against some Gram-positive and many Gram-negative bacteria. [79] It functions by inhibiting a type II topoisomerase (DNA gyrase) and topoisomerase IV, [80][81] necessary to separate bacterial DNA, thereby inhibiting cell division.
August 25, 2024 at 2:00 AM. After a lull of nearly 2 decades, the Food and Drug Administration (FDA) has approved some novel drugs for the treatment of Alzheimer’s disease since 2021. Most of ...
Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. [7] It is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, generalized anxiety disorder, and premenstrual dysphoric disorder. [7]
Rivaroxaban. 2 / 3 metabolized in liver and 1 / 3 eliminated unchanged [4] Rivaroxaban, sold under the brand name Xarelto among others, is an anticoagulant medication (blood thinner) used to treat and prevent blood clots. [8] Specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent blood clots in atrial ...
Drugs approved prior to June 24, 1938 were grandfathered, as long as their manufacturing, ingredients and labeling remained unchanged. In 1962, the Kefauver-Harris Amendment to the FD&C Act gave the FDA the authority to also require efficacy as a condition for drug approval. Drugs approved after June 24, 1938, but before 1962 had a limited time ...