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In October 2018, Akorn received Abbreviated New Drug Application (ANDA) approval from Food and Drug Administration (FDA) for Bimatoprost Ophthalmic Solution, 0.03%. [ 7 ] On May 21, 2020, Akorn filed for Chapter 11 bankruptcy and entered in to a Restructuring Support Agreement with lenders, which represents over 75 percent of its secured debt.
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]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
The FDA allows compounding pharmacies to sell copies of drugs when the medications are in short supply. But compounding pharmacies face stiffer restrictions when a drug shortage is resolved.
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. ... -The U.S. Food and Drug Administration on Wednesday classified ...
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.