Rx Product News

Published Online: Tuesday, June 15, 2010
HOT Rx

Vimovo

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 the symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing nonsteroidal anti-inflammatory 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.

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


Hizentra

Marketed by:
CSL Behring (King of Prussia, PA)

Indication:
CSL Behring announced that the FDA granted marketing approval for Hizentra (immune globulin subcutaneous [human], 20% liquid), the first 20% subcutaneous immunoglobulin (Ig) approved by the FDA, for treating patients diagnosed with primary immunodeficiency (PI). PIs comprise a group of disorders, usually genetic, that cause a failure in all or part of the immune system, preventing the patient from being able to fight off infections caused by everyday germs. Hizentra is a once-weekly Ig replacement therapy that helps these patients by providing protection against infection by maintaining a steady and normal level of Ig in the body. Hizentra is ready to use, as it does not require refrigeration.

Dosage Form:
0.2 g/mL (20%) protein solution for subcutaneous injection

For More Information:
www.hizentra.com


Oravig

Marketed by:
Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies Inc (Woodcliff Lake, NJ)

Indication:
Strativa Pharmaceuticals recently announced that the FDA approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis, more commonly known as thrush, in adults and children aged 16 years and older. The product is an antifungal medication and is the first and only local, oral prescription formulation of miconazole approved for this use in the United States. Oravig adheres to the gum and should be used once daily for 14 consecutive days. Patients should be advised not to crush, chew, or swallow the tablets; the tablet stays in position and gradually dissolves once applied.

Dosage Form:
50-mg buccal tablets

For More Information:
www.strativapharma.com
www.oravig.com


Creon

Marketed by:
Abbott Laboratories (Abbott Park, IL)

Indication:
The FDA recently approved the supplemental new drug application for CREON (pancrelipase) delayed-release capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency [EPI]) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis. CREON is the first medication in its class to have this guidance and information in its prescribing information for use in treating EPI due to CP and pancreatectomy.

Dosage Form:
Capsules: 6000 USP units of lipase; 19,000 USP units of protease; 30,000 USP units of amylase; Capsules: 12,000 USP units of lipase; 38,000 USP units of protease; 60,000 USP units of amylase; Capsules: 24,000 USP units of lipase; 76,000 USP units of protease; 120,000 USP units of amylase

For More Information:
www.CREON.com


Ulesfia

Marketed by:
Shionogi Pharma Inc (Atlanta, GA)

Indication:
After FDA approval, Shionogi Pharma recently introduced Ulesfia (benzyl alcohol lotion). Ulesfia Lotion is a pediculocide indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia Lotion does not have ovicidal activity. The administration directions for Ulesfia include: • Apply Ulesfia Lotion to dry hair, using enough to completely saturate the scalp and hair. • Rinse off with water after 10 minutes. • Repeat treatment in 7 days. Ulesfia is the first FDA-approved nonneurotoxic prescription product for treating head lice.

Dosage Form:
Ulesfia Lotion, 5% in 8-oz bottles

For More Information:
www.shionogipharma.com
800-849-9707


Tropazone

Marketed by:
ECR Pharmaceuticals Co Inc, a subsidiary of Hi-Tech Pharmacal Co Inc (Amityville, NY)

Indication:
Hi-Tech Pharmacal Co Inc announced that it received clearance from the FDA to market Tropazone lotion, a prescription dermatologic product. Tropazone lotion is indicated for the treatment of various dermatologic conditions, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. Tropazone uses patented Lyphazome technology, which is a delivery system that prolongs product activity while enhancing penetration and hydration of the skin.

Dosage Form:
Lotion in 140-g bottle

For More Information:
www.hitechpharm.com
800-899-3116


Silenor

Marketed by:
Somaxon Pharmaceuticals Inc (San Diego, CA)

Indication:
The FDA recently approved the new drug application for Silenor (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance. Sleep maintenance difficulty, defined as waking frequently during the night and/or waking too early and being unable to return to sleep, is the most commonly reported nighttime symptom of insomnia. Silenor is approved for the treatment of both transient (short-term) and chronic (long-term) insomnia characterized by difficulty with sleep maintenance in both adults and elderly patients. Patients should only take Silenor when they are prepared to get a full night’s sleep. Patients should take Silenor within 30 minutes of bedtime and should limit their activities after ingestion to those necessary to prepare for bed. Patients should not consume alcohol or take other drugs that cause drowsiness with Silenor. The initial dosage amount for adults is 6 mg once daily; 3 mg once daily for the elderly. The total daily dose should not exceed 6 mg.

Dosage Form:
Tablets: 3 and 6 mg

For More Information:
www.silenor.com or www.somaxon.com



Zortress


Marketed by:
Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication:
The FDA recently approved Zortress (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor cyclosporine, as well as basiliximab and corticosteroids. Zortress inhibits the proliferation of cells that play a key role in transplant rejection. The use of Zortress in patients at high immunologic risk is not established, nor is the use for prophylaxis in organs other than the kidney. The safety and efficacy in pediatric patients has not been established. The starting oral dose of Zortress is 0.75 mg twice daily. The maintenance dose can be adjusted to obtain everolimus trough concentrations between a 3- and 8-ng/mL target range.

Dosage Form:
Tablets: 0.25, 0.5, and 0.75 mg

For More Information:
www.pharma.us.novartis.com



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