Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

Rx

NEW DRUGS

Flector Patch (diclofenac epolamine) 1.3% from Alpharma, 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, 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, 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, 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), 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, 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), 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 meg per actuation strength. The newly approved strength is 110 meg per actuation, administered once daily in the evening.

Adults with Type 2 diabetes will now be able to use Daiichi Sankyo's Welchol (colesevelam HCl), www.welchol.com, which has gained approval for a new indication. It can now be used to reduce A^sub IC^ in adults with Type 2 diabetes. The bile acid sequestrant was previously approved to reduce elevated LDL-C in patients with primary hypercholesterolemia.

NEW DELIVERY SYSTEM

Merck's antiemetic Emend (fosaprepitant dimeglumine) for Injection has been approved by the FDA. Emend, www.emend.com, is designed to be used in combination with other antiemetics to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy, including high-dose cisplatin. Emend for Injection (115 mg) may replace a 125-mg oral capsule of Emend on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. …

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