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The FDA issued a black box warning in September 2010, for tigecycline regarding an increased risk of death compared to other appropriate treatment. [26] [3] [28] As a result of increase in total death rate (cause is unknown) in individuals taking this drug, tigecycline is reserved for situations in which alternative treatment is not suitable.
Glycylcycline antibiotics have a similar mechanism of action as tetracycline antibiotics. They block protein synthesis hence preventing bacterial reproduction. Both classes of antibiotics bind to the 30S ribosomal subunit to prevent the amino-acyl tRNA from binding to the A site of the ribosome.
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:
(formerly known as TP-434) received FDA approval on August 27, 2018, for treatment of complicated intra-abdominal infections. [54] Sarecycline: 16+ hours (long) (formerly known as WC 3035) received FDA approval on October 1, 2018, for treatment of moderate to severe acne vulgaris. [55] Sarecycline is a narrow-spectrum antibiotic. [56] [57 ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
The FDA has recalled 28 beverages so far in 2024, The Daily Mail reported. All but four of the drinks were recalled because they had drugs, bacteria or harmful chemicals in them that the company ...
Version 3.0 also included drug transporter data, drug pathway data, drug pricing, patent and manufacturing data as well as data on >5000 experimental drugs. Version 4.0 was released in 2014. [ 4 ] This version included 1558 FDA-approved small molecule drugs, 155 biotech drugs and 4200 unique drug targets.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.