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Latest FDA New Drug Approvals

Tekamlo
Tekamlo (aliskiren and amlodipine) is a direct renin inhibitor and calcium channel blocker combination indicated for the treatment of high ...

ella
ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse ...

Suprep
Suprep (sodium sulfate, potassium sulfate, magnesium sulfate) is an osmotic laxative indicated for cleansing of the colon in preparation ...

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Drugs in Development – Not yet approved

E7389
E7389 (eribulin mesylate) is a potential anti-cancer agent in development for the third-line treatment of advanced breast cancer in ...

JZP-6
JZP-6 (sodium oxybate oral solution) is a central nervous system depressant in development for the treatment of fibromyalgia.

Ceplene
Ceplene (histamine dihydrochloride) is a new drug in development for use in conjunction with interleukin-2 (IL-2) as a remission ...

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Lower Blood Pressure May Help Sicker Kidney Patients

WEDNESDAY, Sept. 1 -- Aggressive treatment to lower high blood pressure may help preserve kidney function and prevent the need for dialysis in some black patients with chronic kidney disease. That's the finding of a study published Sept. 2 in the New England Journal of Medicine. "This is not a panacea. We have a lot more to figure out. But our evidence suggests that we have a way to at least...

Double-Dose Plavix Benefits Certain Patients, Study Finds

WEDNESDAY, Sept. 1 -- More isn't necessarily better when prescribing the two drugs commonly used to treat patients who are in danger of having a heart attack, Plavix (clopidogrel) and aspirin, a new study suggests. Two reports on the data find that high doses of Plavix are good for some patients, but not all, while high-dose aspirin is no better than a low dose for preventing new heart attacks,...

Diet Pill Meridia Ups Heart Attack Risk: Study

WEDNESDAY, Sept. 1 -- A new study is linking the popular weight loss drug Meridia to an increased risk of non-fatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems. The finding is stirring mixed reactions from experts. According to the authors of the trial, which was funded by Meridia's maker, Abbott, the...

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FDA Drug Safety Communication: Increased Risk of Death with Tygacil (tigecycline) Compared to Other Antibiotics Used to Treat Similar Infections

Safety AnnouncementAdditional Information for Healthcare Professionals Data Summary     Safety Announcement [09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious...

FDA MedWatch - Tygacil (tigecycline): Label Change - Increased Mortality Risk

AUDIENCE: Infectious Disease, Critical Care Medicine, Internal Medicine ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia,...

Allergan Resolves United States Government Investigation of Past Sales and Marketing Practices Relating to Certain Therapeutic Uses of Botox

IRVINE, Calif.--(BUSINESS WIRE)--Sep 1, 2010 - Allergan, Inc. (NYSE: AGN) today announced that it has reached a resolution with the United States Department of Justice (DOJ) regarding the previously reported Government investigation into Allergan's past U.S. sales and marketing practices relating to certain therapeutic uses of BOTOX® (onabotulinumtoxinA). Allergan has been cooperating with...

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Latest Additions to Drugs.com

Recently added consumer and prescribing information: Tekamlo, Suprep, ella, Xeomin, Lastacaft, Cuvposa, Tribenzor, Veltin, Zuplenz, Glassia ...also see new filings.

July 13 Webinar – FDA’s Safety Monitoring of Approved Vaccines

FDA’s Center for Biologics Evaluation and Research will host a 30-minute webinar on the agency’s efforts to ensure the safety of vaccines. There will be an opportunity to ask questions following the presentation on July 13, 2010, at 2:00 p.m. EDT. More information is available here: http://www.drugs.com/fda-consumer/july-13-webinar-fda-s-safety-monitoring-of-approved-vaccines-147.html See also, timely FDA Consumer Updates here: http://www.drugs.com/fda-consumer

FDA Announces Collaboration With Drugs.com

A new partnership forged by the two entities provides consumers with a joint resource on Drugs.com that features FDA Consumer Update articles, videos, and slide-shows. It will also bring FDA health information to the Drugs.com’s mobile phone platform at drugs.mobi. “The partnership with Drugs.com means that reliable, useful, and timely health information will be available ...

Drugs.com receives another Webby nomination

We are extremely proud to announce that Drugs.com has been nominated for the prestigious Webby Awards for the second year running. To yet again be judged among the Internet’s top 5 health web sites is indeed an honor. The Webby People’s Voice Awards is also one of the few major awards that invite the public ...

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