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FDA Approves New Eye Pressure Drop Formulation 4 Sep 2010

WASHINGTON (MedPage Today) -- The FDA approved a new formulation of the drug bimatoprost (Lumigan) in a 0.01% solution as a first-line treatment to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Tigecycline Label to Warn on Increased Death Risk 3 Sep 2010

(MedPage Today) -- A warning that the intravenous antibiotic drug tigecycline (Tygacil) is associated with increased risk of death, compared with other antibiotics, will be added to the product's label, the FDA said.

Allergan Settles Civil and Criminal Charges 1 Sep 2010

(MedPage Today) -- Botox manufacturer Allergan will pay $375 million after pleading guilty to a misdemeanor misbranding charge related to off-label use of the cosmetic drug, a statement on the company's website said.

Opioid Dependence Drug Gets Okay for New Delivery Mode 1 Sep 2010

WASHINGTON (MedPage Today) -- The FDA has approved a new sublingual film formulation of the opioid dependence treatment combination buprenorphrine/naloxone (Suboxone).

CDC, FDA Warn About Fingerstick Devices 28 Aug 2010

WASHINGTON (MedPage Today) -- A joint warning from the FDA and CDC cautioned against reusing fingerstick and point-of-care (POC) blood testing devices because of the potential for transmission of bloodborne illnesses.

Maker Recalls Replacement Hip Devices 27 Aug 2010

(MedPage Today) -- The maker of an artificial hip system issued a voluntary recall of its ASR product line after data indicated a higher than expected need for device replacement surgery five years after the initial procedure.

FDA: Give Time Out to TimeOut Capsules 27 Aug 2010

WASHINGTON (MedPage Today) -- The FDA has issued a warning against yet another product marketed as an "all-natural sexual enhancement" dietary supplement -- this one called TimeOut -- that contains a potentially dangerous analogue of the prescription drug sildenafil, the active ingredient in Viagra.

Novel Combo Pill for Hypertension Approved 27 Aug 2010

(MedPage Today) -- Another type of combination pill for hypertension has won FDA approval -- this time putting a direct renin inhibitor together with a calcium channel blocker.

Huber Needles Recalled 27 Aug 2010

WASHINGTON (MedPage Today) -- The FDA has issued a class I recall, the agency's most serious, for Huber needles that were found to produce cores -- slivers of silicone -- when they penetrate a vascular access port.

Generic Enoxaparin Stays on Market, at Least for Now 26 Aug 2010

(MedPage Today) -- Patients needing anticoagulant therapy can still obtain generic enoxaparin while a lawsuit filed by the branded version's manufacturer is heard, a U.S. District Court judge ruled.

NO Delivery System Recalled 25 Aug 2010

WASHINGTON (MedPage Today) -- The FDA has issued a class I recall -- the agency's most serious -- for the nitric oxide delivery system Inomax because of a pressure switch problem that could be fatal.

Foot Tanner Unsafe Says FDA 24 Aug 2010

WASHINGTON (MedPage Today) -- It's sometimes hard to get your feet tanned, but those who use a portable foot tanning device called the Tootsie Tanner risk overexposure to ultraviolet radiation, the FDA said in a prepared statement.

FDA Panel Roundly Rejects CNS Drug for Fibromyalgia 20 Aug 2010

BETHESDA, Md. (MedPage Today) -- A federal advisory panel has voted 20-2 to recommend that the FDA not grant approval for an expanded indication for sodium oxybate (Xyrem) -- also known as GHB -- to treat fibromyalgia.

Cardio Risks Seen With Parkinson's Drug Trio, FDA Says 20 Aug 2010

WASHINGTON (MedPage Today) -- Patients taking the Parkinson's drug combo carbidopa/levodopa and entacapone (Stalevo) may be at a higher risk for cardiovascular events such as myocardial infarction, stroke, and death, the FDA said in a prepared statement.

Equivocal Message on Duloxetine for Pain from Panel 19 Aug 2010

BETHESDA, Md. (MedPage Today) -- An FDA advisory committee has voted narrowly -- 8 to 6 -- to recommend that the agency expand the indication for the antidepressant duloxetine (Cymbalta) to treat chronic musculoskeletal pain.

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