Branded pharmaceuticals, generics, OTCs, home-health products, health and beauty items
Evista (raloxifene hydrochloride), the selective estrogen receptor blocker from Eli Lilly & Co., Indianapolis, (317) 277-6583, has been approved for a new indication. It can now be used to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, has approval for two new indications for the broad-spectrum antibiotic Levaquin (levofloxacin). One approval covers the use of a 750-mg daily dosage of Levaquin IV, Levaquin Oral Tablets, and Levaquin Oral Solution for five days for the treatment of complicated urinary tract infection and acute pyelonephritis. The other provides for the addition of pediatric safety information for the Oral Tablet, the IV, and the Oral Solution.
NEW DOSAGE STRENGTHS
MedPointe Pharmaceuticals, Somerset, N.J., (800) 526-3840, has FDA approval for a 250-mg tablet for SOMA (carisoprodol) for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. The recommended dose is 250 mg three times a day and at bedtime. SOMA 250 mg offers relief comparable to that provided by already available SOMA 350 mg but with less drowsiness.
Sanofi-aventis, Bridgewater, N.J., (908) 243-6000, and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, have received approval for a 300-mg tablet of the antiplatelet medication Plavix (clopidogrel bisulfate). This new strength will provide the approved loading dose for acute coronary syndrome.
Xyzal (levocetirizine dihydrochloride) is now available from UCB Pharma, Atlanta, (800) 477-7877, and Sanofi-aventis, Bridgewater, N.J., (908) 243-6000. The once-daily medication is indicated for treating indoor and outdoor allergies as well as chronic idiopathic urticaria. It is approved for use in adults and children six years of age and older.