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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).
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 ...
The Act also requires the drug innovator to give the FDA the numbers of patents it believes cover its drug; the FDA does not evaluate whether the patents cover the drug, but publicly lists them in the Orange Book, and these are the patents the life of which is extended if there are regulatory delays.
However, many women and doctors — particularly primary care physicians — aren't aware that the data has changed and continue to avoid hormone therapy, Dr. G. Thomas Ruiz, lead ob-gyn at ...
Ciprofloxacin is a fluoroquinolone antibiotic used to treat a number of bacterial infections. [5] This includes bone and joint infections, intra-abdominal infections, certain types of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others. [5]
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Colchicine in combination with probenecid has been FDA-approved before 1982. In July 2009, colchicine won FDA approval in the United States as a stand-alone drug for the treatment of acute flares of gout and familial Mediterranean fever. It had previously been approved as an ingredient in an FDA-approved combination product for gout. The ...
April 29, 2024 at 4:09 PM. (Reuters) -The U.S. Food and Drug Administration (FDA) granted full approval for Pfizer's drug for treating cervical cancer patients whose disease had progressed...
An FDA director who oversaw the approval of OxyContin got a $400K gig at Purdue Pharma a year later. A new book by Patrick Radden Keefe reported on these claims and on the billionaire Sackler family.
Paroxetine, sold under the brand names Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. 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.
The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects.
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