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FDA Announces Labeling Changes Following Cardiac Adverse Events With Addiction Drug
The FDA is strengthening warnings to physicians about serious cardiac adverse events associated with Orlaam (levomethadyl acetate HC), a drug for opiate addiction treatment. As of March 30, 2001, 10 cases of serious arrhythmias have been submitted to FDA through MedWatch -- FDA’s safety surveillance program. An estimated 33,000 patients have been treated with Orlaam to date. more
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Prescribing Information: Orlaam
Orlaam is approved for the treatment of opiate addiction. The drug has no other approved uses. Orlaam can be taken less frequently than methadone, reducing the number of necessary clinic visits for patients. Get the full prescribing information in today's issue of Vidyya. more
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FDA Approves Second Non CFC-Containing Albuterol Inhaler
The FDA today approved Ventolin HFA (albuterol sulfate HFA), a new version of the Ventolin metered-dose inhaler (MDI) for asthma and other obstructive lung diseases. Unlike the currently marketed version of Ventolin, also manufactured by GlaxoSmithKline, this new inhaler does not contain chlorofluorocarbons (CFCs) to propel the medication. more
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Prescribing Information: Ventolin
Get the full prescribing information for Ventolin. The information includes an illustrated section for patients which demonstrates the correct way to use the Ventolin inhaler. Ventolin is a fast-acting beta2-agonist that is used as a rescue medicine. It acts within minutes to help relieve bronchospasm and its symptoms for up to 6 hours. more
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FDA Issues New Requirements For Bolstering Child Protection In Clinical Trials
The FDA is issuing an interim rule to provide additional safeguards for children enrolled in clinical trials of medical products the agency regulates. This action was mandated by the Children’s Health Act of 2000 that calls for specific measures to better promote the unique needs of children participating in clinical trials. more
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