FDA recommends removing Avastin’s breast cancer indication
The U.S. Food and Drug Administration (FDA) is recommending that the breast cancer indication for Avastin be removed from its label “because the drug…
News
Propoxyphene taken off market
Xanodyne Pharmaceuticals, Inc., which makes Darvon and Darvocet, the brand versions of the prescription pain medication propoxyphene, has agreed to withdraw the medication from…
New lupus drug one step closer to approval
An advisory panel has recommended the U.S. Food and Drug Administration approve Benlysta; it would be the first new drug approved to treat Lupus…
FDA approves new drug for schizophrenia
The U.S. Food and Drug Administration has approved Latuda (lurasidone HCL) tables for the treatment of adults with schizophrenia. Read more here.
Abbott withdraws Meridia from market
On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a request from the U.S.…
New safety information for Invirase
The U.S. Food and Drug Administration announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir).…
New warning added for gonadotropin-releasing hormone agonists
The U.S. Food and Drug Administration has asked manufacturers to add new labeling warnings for gonadotropin-releasing hormone (GnRH) agonists, mostly used to treat men…
Some fentanyl transdermal patches recalled
The U.S. Food and Drug Administration announced that Actavis Inc. has recalled 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches from wholesale…
How to revive the FDA
The Oct. 6 New England Journal of Medicine includes a perspective on how to “revive” the U.S. Food and Drug Administration. Read it here.
Amgen, FDA announce voluntary recall of Epogen and Procrit
On Sept. 24, Amgen and the U.S. Food and Drug Administration announced that Amgen is voluntarily recalling certain lots of Epogen and Procrit (Epoetin…
Hospira infusers recalled
On Sept. 10, the U.S. Food and Drug Administration announced the recall of the Hospira Symbiq One-Channel and Two-Channel Infusers because of the potential…
Free online course on FDA drug regulation
Access “The Past, Present, and Future of FDA Human Drug Regulation,” a free educational program from the U.S. Food and Drug Administration is available…
FDA recommends removing Avastin’s breast cancer indication
The U.S. Food and Drug Administration (FDA) is recommending that the breast cancer indication for Avastin be removed from its label “because…
Propoxyphene taken off market
Xanodyne Pharmaceuticals, Inc., which makes Darvon and Darvocet, the brand versions of the prescription pain medication propoxyphene, has agreed to withdraw the…
New lupus drug one step closer to approval
An advisory panel has recommended the U.S. Food and Drug Administration approve Benlysta; it would be the first new drug approved to…
FDA approves new drug for schizophrenia
The U.S. Food and Drug Administration has approved Latuda (lurasidone HCL) tables for the treatment of adults with schizophrenia. Read more here.
Abbott withdraws Meridia from market
On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a request from…
New safety information for Invirase
The U.S. Food and Drug Administration announced that new safety information has been added to the label for the HIV antiviral drug…
New warning added for gonadotropin-releasing hormone agonists
The U.S. Food and Drug Administration has asked manufacturers to add new labeling warnings for gonadotropin-releasing hormone (GnRH) agonists, mostly used to…
Some fentanyl transdermal patches recalled
The U.S. Food and Drug Administration announced that Actavis Inc. has recalled 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches…
How to revive the FDA
The Oct. 6 New England Journal of Medicine includes a perspective on how to “revive” the U.S. Food and Drug Administration. Read…
Amgen, FDA announce voluntary recall of Epogen and Procrit
On Sept. 24, Amgen and the U.S. Food and Drug Administration announced that Amgen is voluntarily recalling certain lots of Epogen and…
Hospira infusers recalled
On Sept. 10, the U.S. Food and Drug Administration announced the recall of the Hospira Symbiq One-Channel and Two-Channel Infusers because of…
Free online course on FDA drug regulation
Access “The Past, Present, and Future of FDA Human Drug Regulation,” a free educational program from the U.S. Food and Drug Administration…
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