New products comprising prescription drugs, OTCs, healthcare items, beauty care.
CSL Behring, King of Prussia, Pa., (610) 878-4000, has a newly approved indication for Humate-P (antihemophilic factor/vonWillebrand [vWD] factor complex). Originally approved for use in treating and preventing bleeding in hemophilia A in adults, the drug can now be used for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe vWD.
Oscient Pharmaceuticals, Waltham, Mass., (781) 398-2300, has been granted approval for Factive (gemifloxacin mesylate) Tablets for a five-day treatment of mild to moderate community-acquired pneumonia. The five-day treatment with Factive Tablets was approved originally for treatment of acute bacterial exacerbations of chronic bronchitis.
Cincinnati-based Duramed Pharmaceuticals, (513) 731-9900, has approval for a new indication for Enjuvia (synthetic conjugated estrogens, B). The product can now be used to treat moderate to severe vaginal dryness and pain with intercourse, symptoms associated with menopause. Enjuvia was approved earlier for treating moderate to severe vasomotor symptoms associated with menopause.
NEW DOSAGE STRENGTHS
Duramed Pharmaceuticals has added a 0.9-mg tablet to its Enjuvia product line, indicated for treating menopausal symptoms of vaginal dryness and pain. Other available dosage strengths of the medication include 0.3, 0.45, 0.625, and 1.25 mg.
Approval has been granted to Sanofi-Aventis, Bridgewater, N.J., (908) 243-6000, for the Lantus Solo Star prefilled disposable insulin pen for once-daily 24-hour dosing of Lantus (insulin glargine). According to the company, this is the only prefilled disposable insulin pen that permits patients to administer doses from one to 80 units in a single injection. The drug is indicated for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes.
Minneapolis-based Medtronic Inc., (763) 514-4000, has received FDA approval for its REAL-Time continuous glucose monitoring device for children and teens ages seven to 17. It displays glucose values and trend graphs, allowing patients to see how diet, exercise, medication, and lifestyle affect their glucose level.