Rx Product News
Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)
Indication: The FDA approved Tekamlo (aliskiren and amlodipine) tablets, a once-daily, single-pill combination therapy for the treatment of hypertension. Tekamlo combines the direct renin inhibitor Tekturna (aliskiren) with the dihydropyridine calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals or whose blood pressure is not adequately controlled with monotherapy, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.
Dosage Form: Tablets (aliskiren/amlodipine): 150 mg/5mg, 150 mg/10 mg, 300 mg/5 mg, and 300 mg/10 mg
For More Information: www.pharma.us.novartis.com
Marketed by: Novo Nordisk (Princeton, NJ)
Indication: Novo Nordisk announced the FDA approval of NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8-mg vial size. NovoSeven RT is indicated for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors and in patients with congenital FVII deficiency. There is an increased risk of arterial thromboembolic events when NovoSeven RT is administered outside these currently approved indications. The new 8-mg vial allows rapid initiation and administration for patients who require a larger dose. The FDA also extended the shelf life for all vial sizes to 36 months.
Dosage Form: Lyophilized powder in single-use vials for intravenous bolus injection: 1, 2, 5, and 8 mg of recombinant Factor VIIa
For More Information: www.novosevenrt.com
Marketed by: Dendreon Corp (Seattle, WA)
Indication: Dendreon Corp announced that the FDA approved Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer. Provenge is designed to induce an immune response against prostatic acid phosphatase, an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.
Dosage Form: Each dose of Provenge contains a minimum of 50 million autologous CD54+ cells activated with PAPGM-CSF, suspended in 250 mL of Lactated Ringer’s Injection, USP, in a sealed, patient-specific infusion bag
For More Information: www.provenge.com
Marketed by: Mission Pharmacal Co (San Antonio, TX)
Indication: Mission Pharmacal Co introduces Uribel (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate) capsules for oral administration for the treatment of the symptoms of irritative voiding due to lower urinary ingredients that work to alleviate pain and spasms and eliminate bacteria. The dose for adults is 1 capsule 4 times daily followed by liberal fluid intake. Uribel is classified as pregnancy category C.
Dosage Form: Capsules: Each capsule contains 118 mg methenamine, 40.8 mg sodium phosphate monobasic, 36 mg phenyl salicylate, 10 mg methylene blue, and 0.12 mg hyoscyamine sulfate
For More Information: www.missionpharmacal.com