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Latest FDA New Drug Approvals

Tribenzor
Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) is a three-in-one combination product taken once-daily for the treatment of ...

Veltin
Veltin Gel (clindamycin phosphate and tretinoin) is a combination of an antibiotic and a retinoid indicated for the topical treatment of ...

Alsuma
Alsuma (sumatriptan injection) is a triptan indicated for the acute treatment of migraine attacks and cluster headache episodes.

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Drugs in Development – Not yet approved

Brilinta
Brilinta (ticagrelor) is an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with ...

cladribine
Cladribine (Tablets) is an investigational oral formulation of cladribine under review as a therapy for reducing relapses in people ...

TMC278
TMC278 (rilpivirine) is an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for use with other ...

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Drugs.com is the most popular, comprehensive and up-to-date source of drug information online. Providing free, peer-reviewed, accurate and independent advice on more than 24,000 prescription drugs, over-the-counter medicines & natural products.

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Cuvposa Approved for Chronic Drooling in Children
THURSDAY, July 29 -- Cuvposa (glycopyrrolate) Oral Solution has been approved by the U.S. Food and Drug Administration to treat chronic drooling in children aged 3 to 16. Neuromuscular problems among the developmentally disabled is a prime cause of chronic drooling in this age group, the agency said in news release. The drug is designed to reduce the amount of saliva produced. Glycopyrrolate...
Menopause Treatment Could Harm Kids, Pets, FDA Warns
THURSDAY, July 29 -- Evamist, a drug used to reduce menopause-related hot flashes in women, may harm children and pets who have skin contact with the drug, the U.S. Food and Drug Administration said Thursday. The product, which is sprayed on the skin between the elbow and wrist and on the inside of the forearm, contains an estrogen hormone called estradiol. Evamist was approved for use in the...
Doctors, Patients Rarely on Same Page
THURSDAY, July 29 -- Doctors and patients are often out of sync with each other when it comes to what patients believe about their illnesses, including to what extent the patient is to blame and what's the best way to manage the problem, new research shows. The underlying cause of the disconnect is a lack of communication, researchers said. Patients who were "active participants" in their care...

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Latest Pharma Industry News

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FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes
WILMINGTON, DE – July 28, 2010 – AstraZeneca today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca’s investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes (ACS). The Advisory Committee voted as follows: Questions to...
Tibotec Pharmaceuticals Submits New Drug Application for Investigational Once-Daily HIV Treatment TMC278 to U.S. Food and Drug Administration
TITUSVILLE, N.J., July 26 /PRNewswire/ -- Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If...
FDA MedWatch - Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
ROCKVILLE, Md., July 29, 2010-ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood...

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Latest Additions to Drugs.com

Recently added consumer and prescribing information: Tribenzor, Veltin, Zuplenz, Glassia, Alsuma, Butrans, Dulera, Staxyn, Cysview, Jevtana ...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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