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In July 2009, the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares [66]). This resulted in a 3-year regulatory market exclusivity in the acute and chronic gout indications and a 7-year exclusivity on the FMF indication.
Although the exact mechanism of colchicine is not fully understood, its anti-inflammatory effect for pericarditis appears to be related to its ability to inhibit microtubule self-assembly, resulting in decreased leucocyte motility and phagocytosis. Other non-FDA-approved uses include actinic keratosis, amyloidosis, Peyronie's disease, and ...
The dosage of 0.6mg per 5ml (teaspoon) can fill that important void in treatment where patients may have difficulty swallowing pills. It can also provide more adjustable dosing, titration and dose-reduction options in specific populations, especially for gout patients with renal or hepatic impairment and reduce side effects with the goal to ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The U.S. Food and Drug Administration (FDA) has officially announced a ban on red dye No. 3, or erythrosine, from foods and oral medications due to a potential cancer risk.. Food manufacturers ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Pfizer said it plans to present the data at an upcoming medical meeting and discuss it with global health regulators for a potential approval. Pfizer's bladder cancer therapy meets main goal in ...
The FDA is reviewing a drug that could cure sickle cell anemia. Right now bone marrow or stem cell transplants are the only FDA-approved cures.