New Products: March 10, 2008

NEW DRUGS

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.