FDA approves drug to reduce risk of preterm birth
The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant women with…
News
FDA looks to improve medical device review process
The U.S. Food and Drug Administration plans to implement changes in 2011 designed to improve review of medical devices. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm.
FDA approves head lice treatment
The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in patients 4 years and…
FDA advises women with breast impants
The U.S. Food and Drug Administration says women with breast implants may have a “very small, but increased risk” of developing anaplastic large cell…
Metronidazole recall announced
The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012…
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…
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…
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.
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…
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…
FDA approves drug to reduce risk of preterm birth
The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant…
FDA looks to improve medical device review process
The U.S. Food and Drug Administration plans to implement changes in 2011 designed to improve review of medical devices. Read more at…
FDA approves head lice treatment
The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in patients 4…
FDA advises women with breast impants
The U.S. Food and Drug Administration says women with breast implants may have a “very small, but increased risk” of developing anaplastic…
Metronidazole recall announced
The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration…
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…
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.
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…
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…
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