Publication

Article

Pharmacy Times

July 2010 Digestive Health
Volume76
Issue 7

Rx Products

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

Marketed by:

AstraZeneca (Wilmington, DE) and POZEN Inc (Chapel Hill, NC)

Indication:

AstraZeneca and POZEN Inc recently announced that the FDA approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing nonsteroidal anti-inflam matory drug (NSAID)-associated gastric ulcers. The product is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor. VIMOVO is not recommended for use in children younger than 18 years of age.

Dosage Form:

Delayed-release tablets: 375 mg/20 mg or 500 mg/20 mg of naproxen and esomeprazole magnesium

For More Information:

www.vimovo.com

800-236-9933

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, and D3, and 300 mg of plantbased 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

Nasonex

Marketed by:

Merck & Co Inc (Whitehouse Station, NJ)

Indication:

Merck & Co Inc recently announced a new indication for their corticosteroid allergy treatment, Nasonex (mometasone furoate monohydrate). Nasonex is now indicated for the treatment of nasal congestion associated with seasonal allergic rhinitis in patients 2 years of age and older. Nasonex is also indicated for the treatment of nasal symptoms of allergic rhinitis, the prophylaxis of seasonal allergic rhinitis, and the treatment of nasal polyps.

Dosage Form:

Nasal spray: 50 mcg of mometasone furoate in each 100-microliter spray

For More Information:

www.nasonex.com

Marketed by:

Purdue Pharma LP (Stamford, CT)

Indication:

The FDA recently approved a reformulation of controlled-release OxyContin, which has been designed to help discourage misuse and abuse of the medication. The reformulation has met FDA criteria for bioequivalence to the original formulation, which means there is no significant difference in the rate and extent of absorption of the therapeutic ingredient. OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. OxyContin is not intended for use on an as-needed basis. OxyContin continues to be a CII controlled substance with all the attendant risks of Schedule II opioids, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as “psychological dependence”). The full prescribing information contains warnings about the potential for abuse, diversion, overdose, and addiction, including a boxed warning.

Dosage Form:

Tablets: 10, 15, 20, 30, 40, 60, and 80 mg

For More Information:

www.purduepharma.com

www.pharma.com/pressroom/news/OxycontinPI.pdf

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 (hormonerefractory) 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 PAP-GMCSF, suspended in 250 mL of Lactated Ringer’s Injection, USP in a sealed, patient-specific infusion bag.

For More Information:

www.provenge.com

ON THE WEB: For more Rx Product News, go to www.PharmacyTimes.com.

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