NEW DRUGS
Flector Patch (diclofenac epolamine) 1.3% from Alpharma, http://www.alpharma.com/ is an anti-inflammatory that provides a new alternative to nonsteroidal drugs. The patch is 4 inches by 5.5 inches and contains
180 mg of diclofenac epolamine and has also demonstrated analgesic results.
A combination antihypertensive Tekturna HCT (aliskiren, hydrochlorothiazide) has been approved by the FDA. The drug contains both a direct renin inhibitor and diuretic
in a single tablet. The new combination tablet from Novartis, http://www.tekturnahct.com/, will be marketed in four strengths (aliskiren/hydrochlorothiazide): 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300
mg/25 mg.
Moxatag (amoxicillin extended-release) Tablets 775 mg from MiddleBrook Pharmaceuticals, http://www.middlebrookpharma.com/, has been approved to treat adults and children 12 and older with pharyngitis and/or tonsillitis secondary to strep throat.
The company claims that its product is the only once-daily amoxicillin product approved in this country.
NEW INDICATIONS
Genentech, http://www.gene.com/, has received a newly approved indication for Herceptin (trastuzumab). The drug can now be used as a single agent for the adjuvant treatment of HER2-overexpressing node-negative
or node-positive breast cancer, following multi-modality anthracycline-based therapy. The drug is for IV infusion only.
Abbott's biologic Humira (adalimumab), http://www.humira.com/, has been approved by the FDA for two more indications—the treatment of moderate to severe chronic plaque psoriasis and to
reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). Adalimumab
is also approved for the treatment of ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and Crohn's disease.
Mycamine (micafungin sodium), an injectable fungicidal agent, has been approved for the treatment of candidemia, acute disseminated
candidiasis, candida peritonitis, and abscesses. The Astellas Pharma, http://www.astellas.com/, drug inhibits an enzyme essential for fungal cell-wall synthesis and is available in 50- and 100-mg vials.
The Asmanex Twisthaler (mometasone furoate inhalation powder), http://www.asmanex.com/, from Schering-Plough, is now approved for the maintenance treatment of asthma as a preventative therapy in patients ages
four to 11 years old. It was previously approved in patients 12 years of age and older in 220 mcg per actuation strength.
The newly approved strength is 110 mcg per actuation, administered once daily in the evening.
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