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Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant for the indication and manufacturers are allowed to market their drug for the indication. [2] A drug can have more than one FDA labeled indication, which means that it can be used for multiple medical conditions. [5 ...
Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR §§ 312.23, 312.24. These are most commonly used for life-threatening conditions for which there is no standard treatment.
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
Amisulpride is approved and used at low doses in the treatment of dysthymia and major depressive disorder. [10] [20] [11] [21] [22] [23] Whereas typical doses used in schizophrenia block postsynaptic dopamine D 2-like receptors and reduce dopaminergic neurotransmission, low doses of amisulpride preferentially block presynaptic dopamine D 2 and D 3 autoreceptors and thereby disinhibit dopamine ...
Fluorouracil has been given systemically for anal, breast, colorectal, oesophageal, stomach, pancreatic and skin cancers (especially head and neck cancers). [12] It has also been given topically (on the skin) for actinic keratoses, skin cancers and Bowen's disease [12] (a type of cutaneous squamous-cell carcinoma), and as eye drops for treatment of ocular surface squamous neoplasia. [13]
It is also being studied to treat a number of other viral infections, including SARS-CoV-2. [4] Like the experimental antiviral drugs T-1105 and T-1106, it is a pyrazinecarboxamide derivative. [5] It is being developed and manufactured by Toyama Chemical (a subsidiary of Fujifilm) and was approved for medical use in Japan in 2014. [6]
The drug was discovered by a subsidiary of SK Group, which licensed rights outside of eleven countries in Asia to Aerial Pharma in 2011. [8] In addition to its approved indication of excessive sleepiness, solriamfetol is under development for certain other uses including the treatment of attention deficit hyperactivity disorder (ADHD), binge ...
Fluciclovine is a [18 F]-tagged synthetic analog of the amino acid L-leucine.[11] [12] FACBC uptake by the tumor is related to functional activity of two amino acid transporters, [13] specifically sodium-dependent system ASC, with a lesser contribution by sodium-independent system L. [12] Although it is handled by the amino acid transporter system, it does not undergo terminally incorporative ...