Recent News & Comments About food and drug administration
New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA
MONDAY, May 21 (HealthDay News) -- The new blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found.
U.S. states urge return of drug used in executions
WASHINGTON (Reuters) - Fifteen states asked the U.S. Justice Department on Monday for help in obtaining an anesthesia drug they use in executions but that a federal judge said in March was illegally imported. The dispute is playing out in a lawsuit over whether the U.S. Food and Drug Administration has the authority to allow shipments of the sedative sodium thiopental into the country, even ...
FDA staff sends mixed message on J&J drug Xarelto
WASHINGTON (Reuters) - U.S. drug reviewers had mixed opinions about whether Johnson & Johnson blood thinner Xarelto reduced the risk of new heart attacks and strokes in people with heart problems, setting the stage for heated debate by outside experts later this week. Some U.S. Food and Drug Administration staff members raised doubts about how well the drug worked, given the high number of ...
Noven Confirms Filing of Abbreviated New Drug Application for Generic Lidocaine Patch 5%
Noven Pharmaceuticals, Inc. today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market its lidocaine topical patch 5%.
FDA says Xarelto reduced deadly heart attacks
The Food and Drug Administration said Monday that a blood thinner from Johnson & Johnson appears to reduce life-threatening blood clots in high-risk patients, although it also increases the risk of internal bleeding.
Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration ...
SAN FRANCISCO, CA and TOKYO-- - Medivation, Inc. and Astellas Pharma Inc. announced that Medivation has submitted a New Drug Application to the U.S. Food and Drug Administration for enzalutamide . The ...
FDA Reviewer Backs Expanded Approval Of Bayer, J&J's Xarelto
A Food and Drug Administration medical reviewer recommended the agency expand the approval of Johnson & Johnson's (JNJ) and Bayer AG's (BAYRY, BAYN.XE) anticlotting drug Xarelto to treat patients with a heart problem known as acute coronary syndrome.
Apricus Biosciences Granted Regulatory Meeting With FDA for Femprox(R) for the Treatment of Female Sexual Arousal ...
SAN DIEGO -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (http://www.apricusbio.com) announced today that the United States ("U.S.") Food and Drug Administration ...
FDA Approves New Labeling for ISENTRESS® (raltegravir) to Include 156-Week Data Demonstrating Long-Term Efficacy ...
Merck , known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration approved a labeling update for ISENTRESS® Film-coated Tablets to include 156-week data from the STARTMRK study with ISENTRESS in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.
Press Release
Noven Pharmaceuticals Inc. Posted on:22 May 12 Noven Pharmaceuticals, Inc. today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5%. Noven’s lidocaine topical patch 5% is a generic version of Endo Pharmaceuticals’ Lidoderm®.
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