Found 342 datasets matching "drug-safety".
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Background The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo...
Search relevance: 171.57 | Views last month: 0 -
POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety evaluators have access to an...
Search relevance: 82.36 | Views last month: 7 -
Background Decisions on treatment are guided, not only by the potential for benefit, but also by the nature and severity of adverse drug reactions. However, some researchers have found...
Search relevance: 75.02 | Views last month: 2 -
These data are part of NACJD's Fast Track Release and are distributed as they were received from the data depositor. The files have been zipped by NACJD for release, but not checked or processed...
Search relevance: 50.75 | Views last month: 0 -
On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the Act extends eligibility for...
Search relevance: 47.95 | Views last month: 37 -
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and...
Search relevance: 47.62 | Views last month: 20 -
The particle size of modafinil can have a significant effect on the potency and safety profile of the drug. The invention describes a process for the preparation of certain modafinil...
Search relevance: 43.75 | Views last month: 0 -
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act) to notify FDA of a...
Search relevance: 43.75 | Views last month: 19 -
The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by symptom, vaccine product,...
Search relevance: 42.92 | Views last month: 8 -
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's...
Search relevance: 42.70 | Views last month: 98 -
Egaten is a prescription medication containing triclabendazole, an anthelmintic drug that treats parasitic infections by inhibiting certain liver enzymes. It is available as 250mg oral tablets...
Search relevance: 41.26 | Views last month: 0 -
Baxdela is a prescription antibiotic tablet containing delafloxacin meglumine, used to treat certain bacterial infections. It belongs to the fluoroquinolone class and is taken orally. Manufactured...
Search relevance: 41.26 | Views last month: 0 -
Naproxen Sodium is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain, reduce inflammation, and lower fever. This film-coated tablet contains 220 mg of naproxen...
Search relevance: 40.94 | Views last month: 0 -
Sandostatin (octreotide acetate) is an injectable prescription medication manufactured by Novartis Pharmaceuticals Corporation. It acts as a somatostatin analog, administered intravenously or...
Search relevance: 40.87 | Views last month: 0 -
Ketorolac Tromethamine is a prescription non-steroidal anti-inflammatory drug (NSAID) used for short-term pain relief, such as after surgery. It comes as 10 mg oral tablets, manufactured by...
Search relevance: 40.87 | Views last month: 0 -
The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, received since January 1990...
Search relevance: 40.63 | Views last month: 1 -
Fragmin (dalteparin sodium) is a low-molecular-weight heparin anticoagulant used to prevent and treat blood clots, such as deep vein thrombosis. It's administered as a subcutaneous injection and...
Search relevance: 40.57 | Views last month: 0 -
Plaquenil (hydroxychloroquine sulfate) is a prescription tablet used to treat malaria and certain autoimmune conditions like rheumatoid arthritis and lupus. Each tablet contains 200 mg of the...
Search relevance: 40.53 | Views last month: 0 -
Hydroxyzine Hydrochloride is a prescription antihistamine medication used to treat allergies, anxiety, and itching. It comes as a 25 mg oral tablet, manufactured by Teva Pharmaceuticals USA, Inc....
Search relevance: 40.53 | Views last month: 0 -
Cetirizine Hydrochloride is a prescription antihistamine used to relieve allergy symptoms such as runny nose, itchy eyes, sneezing, and hives. It comes as an oral solution with 1 mg/mL strength,...
Search relevance: 40.53 | Views last month: 0
