/publications/issue/2010/July2010/RxProductNews-0710

Rx Product News

Author:

HOT Rx

Prolia

Marketed by:

Amgen Inc (Thousand Oaks, CA)

Indication:
Amgen Inc announced the FDA approval of Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture, or multiple risk factors for fracture); or patients who have failed to respond to or are intolerant of other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every-6-month, 60-mg subcutaneous injection administered by a health care professional. Patients should be advised to take calcium 1000 mg daily and at least 400 IU vitamin D daily.

Dosage Form:
Single-use prefilled syringe containing 60 mg in a 1-mL solution Single-use vial containing 60 mg in a 1-mL solution

For More Information:
www.prolia.com

Menveo

Marketed by:
Novartis AG (Basel, Switzerland)

Indication:
Novartis recently announced the FDA approval of Menveo (meningococcal [groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine), a quadrivalent meningococcal conjugate vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 11 to 55 years of age. The number of meningococcal disease cases varies in the United States, ranging between 1000 and 3000 cases per year.

Dosage Form:
Solution for injection (0.5-mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single-dose vials

For More Information:
www.novartis.com

BD Ultra-Fine Nano

Marketed by:

Becton, Dickinson and Co (Franklin Lakes, NJ)

Indication:
Becton, Dickinson and Co (BD) recently announced the launch of BD Ultra-Fine Nano—the world’s smallest pen needle. The BD Nano pen needle is proven to be as effective as longer needles for diabetes patients of all body types who inject insulin or glucagon-like peptide-1 to manage the disease. Needle anxiety is one of the reasons that one fifth to one third of patients with diabetes are hesitant or unwilling to give themselves injections. The BD Nano pen needle has a short length (4 mm) and thin gauge (32 G), which may help people with diabetes adhere to an insulin injection regimen.

For More Information:
www.bd.com



PreNexa Prenatal Vitamins

Marketed by:

Upsher-Smith Laboratories Inc (Maple Grove, MN)

Indication:
Upsher-Smith Laboratories Inc recently announced the availability of a new formulation of PreNexa Rx prenatal vitamins with changes to the amounts of folic acid and iron. The newest formulation of PreNexa contains 1.25 mg of folic acid and 27 mg of iron—2 essential nutrients that women need during pregnancy, according to the American Congress of Obstetricians and Gynecologists. In addition to folic acid and iron, PreNexa also contains other vitamins and minerals essential for the overall health and well-being of mother and baby including calcium, vitamins B6, C, D3, and 300 mg of plant-based docosahexaenoic acid.

Dosage Form:
Before, during, and/or after pregnancy, 1 softgel capsule daily or as directed by a physician

For More Information:
www.prenexa.com
800-654-2299

Wilate

Marketed by:

Octapharma USA (Hoboken, NJ)

Indication:
Octapharma USA announced the availability of wilate, the first replacement therapy developed specifically for von Willebrand Disease (VWD). The FDA approved wilate for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe VWD, as well as for patients with mild or moderate forms of the illness in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Wilate is not indicated for the prophylaxis of spontaneous bleeding episodes, the prevention of excessive bleeding during and after surgery in VWD patients, or for treatment of Hemophilia A.

Dosage Form:
Sterile, lyophilized powder for reconstitution for intravenous injection, provided in the following nominal strengths per vial: 450 IU VWF:RCo and 450 IU FVIII activities in 5 mL; 900 IU VWF:RCo and 900 IU FVIII activities in 10 mL

For More Information:
www.wilateusa.com


Vimpat

Marketed by:

UCB Inc (Atlanta, GA)

Indication:
UCB announced the availability of an oral solution formulation of Vimpat (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in individuals with epilepsy aged 17 years and older. Vimpat is now available in 3 formulations: oral tablets, oral solution, and intravenous injection, enabling maintenance of treatment in any clinical setting. Patients should be advised that Vimpat may cause dizziness, ataxia, and syncope and should be monitored for depression, suicidal thoughts or behavior, and/ or any unusual changes in mood or behavior, as AEDs increase the risk of suicidal behavior and ideation.

Dosage Form:
Oral solution: 10 mg/ mL; also available are 50-, 100-, 150-, and 200-mg tablets and 200 mg/20 mL single-use vial for intravenous use

For More Information:
www.vimpat.com
800-477-7877


Sprix

Marketed by:

Roxro Pharma Inc (Menlo Park, CA)

Indication:
Roxro Pharma Inc announced that the FDA approved SPRIX (ketorolac tromethamine) Nasal Spray, for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level. SPRIX is a prescription intranasal formulation of the analgesic ketorolac, a nonsteroidal anti-inflammatory drug, designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute moderate to moderately severe pain relief. Ketorolac tromethamine is a frequently administered nonnarcotic injectable analgesic for moderately severe pain in US hospitals today. The approval of SPRIX provides acute pain outpatients with a nonnarcotic and easy-to-administer alternative to commonly prescribed opioids.

Dosage Form:
Nasal spray: 15.75 mg of ketorolac tromethamine in each 100-μL spray. Each 1.7-g bottle contains 8 sprays.

For More Information:
www.sprix.com
www.roxropharma.com


Tasigna

Marketed by:

Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication:
Following a priority review, the FDA-approved Tasigna (nilotinib) 150-mg capsules for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna is the first new therapeutic option for newly diagnosed patients since the introduction of Gleevec (imatinib mesylate), providing another option for patients with this blood cancer. Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML.

Dosage Form:
150- and 200-mg hard capsules

For More Information:
www.us.tasigna.com