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Users can now search DailyMed by unique ingredient identifier for an active ingredient and an active moiety.
Under the Orphan Drug Act, the first NDA applicant to receive US FDA approval for a particular active moiety to treat a particular disease with US FDA orphan drug designation is entitled to a seven-year exclusive marketing period for that drug and use, unless the applicant is unable to assure sufficient quantities of the drug or another applicant is able to demonstrate that its version of the drug is clinically superior.
ATR-FTIR is a very useful tool in fingerprint identification of active moiety and excipient molecules.
A change to the active ingredients, dosage forms, and active moiety, as well as an incorrect entry for the Data Universal Numbering System (DUNS) that identifies individual businesses can all trigger an error.
If the active moiety of Fostriecin, which has shown to be an effective inhibitor of PP4 and a weak inhibitor of PP5, is appended to the Norcantharidin, then theoretically the Norcantharidin derivative should be selective towards PP4 and PP5.
The FDA defines bioequivalence as "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
The FDA defines bioequivalence as -the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI (proton pump inhibitor) brand Nexium (esomeprazole magnesium) and presents a potentially more affordable treatment option for gastro-esophageal reflux disease GERD) in adult patients, says Amneal.
Its active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.
Most important, FDA effectively granted Biostratum's first request by stating that products containing pyridoxamine, the active moiety of pyridoxamine dihy-drochloride (Pyridorin), are excluded from the definition of dietary supplements.
Plasma concentrations of the active moiety of risperidone (risperidone plus 9-OH-risperidone), when combined with carbamazepine, were 40% lower than were those of patients on lithium or valproate.
After oral or intravenous administration, dipyrone is rapidly hydrolyzed to the active moiety 4-methylaminoantipyrine (MAA) (8, 9).
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