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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 ...
Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls. Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia [2] [3]
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
The government has acted swiftly to the recommendations made by the Advisory Council on the Misuse of Drugs (ACMD) and we fully support the banning of 15 new synthetic opioids as Class A drugs.
First, a new kind of market exclusivity was introduced, by means of a new five-year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug. [3] This provides market exclusivity for the drug innovator outside of any patent ...
The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, [1] [2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed ...
Diabetes treatment Mounjaro has been on the health regulator's shortage list since late 2022, while weight-loss drug Zepbound was added in April as demand far outstripped supply. The limited ...
Mylanta is a brand of over-the-counter drugs for digestive problems, manufactured by Infirst Healthcare USA under license from McNeil Consumer Healthcare, a division of Kenvue (formerly Pfizer since 2007 following its acquisition). [1] It includes several different products intended to treat heartburn and bloating.