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Levetiracetam, sold under the brand name Keppra among others, is a novel antiepileptic drug [7] used to treat epilepsy. [8] It is used for partial-onset , myoclonic , or tonic–clonic seizures, [ 7 ] and is taken either by mouth as an immediate or extended release formulation or by injection into a vein .
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
Gilead Sciences Inc. (NASDAQ:GILD) has voluntarily recalled one lot of its COVID-19 treatment, Veklury (remdesivir), for Injection 100 mg/vial, after discovering glass particles in the vials. The ...
The batch numbers are in a PDF attached to the FDA recall notice posting. The label for Glenmark Pharmaceuticals Potassium Chloride Extended Release Capsules 100-count bottles, which were recalled ...
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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The WHO recommendations on which medications should or should not be used to treat Covid-19 are continuously updated. As of July 2022, WHO strongly recommended for non-severe cases nirmatrelvir and ritonavir , and recommended conditionally Molnupiravir , Sotrovimab and Remdesivir .