Search results
Results from the WOW.Com Content Network
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]
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 ...
A category for drugs withdrawn from the market after marketing commenced for any reason (voluntarily or involuntarily). For drug candidates that were abandoned prior to being marketed due to side effects, lack of efficacy, superior competitors, or other reasons, see Category:Abandoned drugs
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased. [7]
The U.S. government has previously resisted calls to seize the patents of costly drugs, declining in March to force Pfizer and Astellas Pharma to lower the price of their prostate cancer drug Xtandi.
The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the government's fight against the abuse of drugs and other substances. This law is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants ...
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 ...
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.