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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 other drug-related charge was a misdemeanor charge of distributing the unapproved drug Levothroid in violation of the Federal Food, Drug, and Cosmetic Act. Certain of the criminal activities were revealed with the help of whistleblowers, who received $14 million from the settlement. [11] [12] [13]
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]
[32] and was approved for marketing in Europe in 1989. [citation needed] In October 2001 Forest Laboratories acquired the rights to market the drug in the US. [32] [33] It was approved by the US Food and Drug Administration (FDA) in July 2004. [34] The first generic versions of acamprosate were launched in the US in 2013. [35]
Levothyroxine, a drug used to treat hypothyroidism, can lead to reduced bone mass and density in older adults with normal thyroid levels, a small cohort study has shown.
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Shares of the company rose 14% to $16.19 in morning trading as the drug met the trial's main and secondary goals in patients with the rare disorder that is estimated to affect between 90 and 300 ...
Lithium is approved by the FDA for the treatment of bipolar disorder and is widely prescribed off-label as a treatment for major depressive disorder, [12] often as an augmentation agent. Lithium is recommended for the treatment of schizophrenic disorders only after other antipsychotics have failed; it has limited effectiveness when used alone.
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