Rx Product News

Pharmacy TimesNovember 2009
Volume 75
Issue 11


Marketed by: Meda Pharmaceuticals Inc (Somerset, NJ)

Indication: Meda Pharmaceuticals announced the commercial availability of Edluar (zolpidem tartrate sublingual tablets). Edluar is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. Edluar is the first available under-the-tongue formulation of zolpidem tartrate, the active ingredient in Ambien oral tablets, and the most prescribed treatment for insomnia.

Dosage Form: Tablets: 5 and 10 mg

For More Information: www.edluar.com


Marketed by: Ista Pharmaceuticals Inc (Irvine, CA)

Indication: Ista Pharmaceuticals announced that the FDA approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twicedaily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients 2 years of age and older. Bepreve is a nonsedating, highly selective antagonist of the histamine (H1) receptor.

Dosage Form: Solution containing bepotastine besilate, 1.5%

For More Information: www.istavision.com


Marketed by: King Pharmaceuticals Inc (Bristol, TN)

Indication: King Pharmaceuticals recently announced the FDA approval and subsequent commercial availability of Embeda (morphine sulfate and naltrexone hydrochloride) Extended-release Capsules, a painkiller that is designed to be abuse-resistant. Embeda is a long-acting Schedule II opioid analgesic for the management of moderate-to-severe pain when a continuous, aroundthe- clock opioid analgesic is needed for an extended period of time. It is the first long-acting opioid approved by the FDA designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

Dosage Form: Capsules (morphine sulfate/naltrexone hydrochloride): 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg

For More Information: www.embeda.com www.KingPharm.com



Marketed by: Novartis (Basel, Switzerland)

Indication: The FDA recently approved Novartis’ blood pressure treatment Valturna (aliskiren and valsartan tablets). Valturna is the first and only medicine to treat 2 key points within the renin system, also known as the renin-angiotensin-aldosterone system, an important regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Dosage Form: Tablets (aliskiren and valsartan): 150 mg/160 mg and 300 mg/320 mg

For More Information: www.novartis.com


Marketed by: sanofi-aventis US (Bridgewater, NJ)

Indication: The FDA granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of PUA. Elitek, a recombinant urate oxidase enzyme, was originally approved by the FDA in 2002 to manage PUA levels in pediatric patients receiving anti-cancer treatment and at risk for TLS. It is the first recombinant uricolytic agent approved in the United States to maintain PUA levels in patients receiving anti-cancer therapy. Elitek is indicated for only a single course of treatment.

Dosage Form: 1.5 mg powder per single-use vial; 7.5 mg powder per single-use vial

For More Information: www.elitekinfo.com


Marketed by: Eurand NV (Philadelphia, PA)

Indication: Eurand NV announced that the FDA approved its new drug application for Zenpep (pancrelipase) Delayed-release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) (ie, the inability to properly digest food due to a lack of digestive enzymes made by the pancreas) in patients with cystic fibrosis or other conditions. Zenpep is the only FDA-approved pancreatic enzyme product that has been evaluated in clinical studies in adults and children—including children aged 1 to 12 years—and will offer 4 dosage strengths to meet the varied needs of infants, toddlers, adolescents, and adults with EPI.

Dosage Form: Capsules in 4 dosages: (1) 5000 USP units of lipase; 17,000 USP units of protease; 27,000 USP units of amylase; (2) 10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP units of amylase; (3) 15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP units of amylase; and (4) 20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP units of amylase

For More Information: www.zenpep.com

888-ZENPEP1 (888-936-7371)


Marketed by: Merck & Co Inc (Whitehouse Station, NJ)

Indication: Merck & Co Inc announced that the FDA approved an additional indication for Isentress (raltegravir). The expanded indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatmentexperienced adult patients. It is used in combination with other antiretroviral medicines for the treatment of HIV-1 infection in adult patients.

Dosage Form: Tablets: 400 mg

For More Information: www.isentress.com


Marketed by: Novartis (Basel, Switzerland)

Indication: The FDA approved Extavia (interferon beta-1b), the first in a new portfolio of multiple sclerosis (MS) products from Novartis. It is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training, and reimbursement support services.

Dosage Form: Lyophilized powder containing 0.3 mg of interferon beta- 1b, 15 mg albumin (human), USP, and 15 mg mannitol, USP

For More Information: www.novartis.com

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