FDA approves first generic versions of Singulair to treat asthma, allergies
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- Category: FDA
The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief
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- Category: FDA
U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
European Medicines Agency website on suspected side effect reports now in all 23 EU official languages
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- Category: EMA
The European Medicines Agency has launched its website on suspected side-effect reportsExternal link icon for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.
European Medicines Agency boosts EU transparency
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- Category: EMA
The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised.
FDA approves generic versions of blood thinner Plavix
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- Category: FDA
The U.S. Food and Drug Administration approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
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- Category: FDA
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI).
FDA approves first Boniva generics to treat or prevent osteoporosis
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- Category: FDA
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
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- European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
- FDA approves first generic version of cholesterol-lowering drug Lipitor
- Drug not Shown to be Safe and Effective in Breast Cancer Patients
- European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs
- European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix