Rx Product News

Invega Sustenna

Marketed by: Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc (Titusville, NJ)

Indication: The FDA recently approved Invega Sustenna (paliperidone palmitate) for the acute and maintenance treatment of schizophrenia. It is the first once-monthly, long-acting, injectable atypical antipsychotic. The product is proven to both significantly delay the time to relapse and can help guarantee consistent medication coverage—a key goal of treatment. Although no cure exists for schizophrenia, the symptoms and the risk of relapse (an exacerbation of symptoms) can be managed in most patients with appropriate treatment that includes continuous, long-term therapy with antipsychotic medications.

Dosage Form: Prefilled syringes containing 39, 78, 117, 156, or 234 mg paliperidone palmitate

For More Information: www.invegasustenna.com/invegasustenna/shared/pi/ invegasustenna.pdf

Astepro

Marketed by: Meda Pharmaceuticals Inc (Somerset, NJ)

Indication: Meda Pharmaceuticals recently announced that the FDA approved Astepro (azelastine HCl) Nasal Spray 0.15% for the treatment of symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older. The nasal spray is the first nasal antihistamine to offer convenient, once-daily dosing for patients who are affected by seasonal allergies. Astepro Nasal Spray 0.15% relieves rhinitis symptoms, including nasal congestion, without an added decongestant such as pseudoephedrine and is formulated with azelastine, a leading nasal antihistamine in the treatment of seasonal rhinitis in the United States.

Dosage Form: Seasonal allergic rhinitis: 1 or 2 sprays in each nostril twice daily or 2 sprays in each nostril once daily; perennial allergic rhinitis: 2 sprays in each nostril twice daily

For More Information: www.astepro.com

Onglyza

Marketed by: AstraZeneca (Wilmington, DE) and Bristol-Myers Squibb (Princeton, NJ)

Indication: Bristol-Myers Squibb and AstraZeneca announced that the FDA approved Onglyza (saxagliptin), a dipeptidyl peptidase-4 inhibitor. The product is indicated as an adjunct to diet and exercise to improve glycemic control in adults for the treatment of type 2 diabetes mellitus. Onglyza once daily can be used in combination with commonly prescribed oral antidiabetic medications—metformin, sulfonylureas, or thiazolidinediones— or as monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. Onglyza should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. Onglyza has not been studied in combination with insulin.

Dosage Form: Tablets: 2.5 and 5 mg

For More Information: www.onglyza.com

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Hiberix

Marketed by: GlaxoSmithKline (Philadelphia, PA)

Indication: GlaxoSmithKline received accelerated FDA approval for Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) as a booster dose in children 15 months through 4 years of age (prior to 5 years of age), in response to a US shortage of the vaccine to protect infants from Haemophilus influenzae type b (Hib). Hib is an often severe and potentially deadly bacterial infection that can cause meningitis. The Centers for Disease Control and Prevention recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.

Dosage Form: Solution for injection (0.5-mL dose) supplied as vials of lyophilized vaccine to be reconstituted with the accompanying saline diluent in prefilled syringes

For More Information: www.hiberix.com

Zithranol-RR

Marketed by: Elorac Inc (Vernon Hills, IL)

Indication: Elorac Inc announced the launch of Zithranol-RR (anthralin rapid-release microcrystalline encapsulated cream, 1.2%), a novel, steroid-free topical treatment for mild-to-moderate plaque psoriasis. The product provides an advanced delivery system for anthralin achieving long remission times with no long-term side effects in a steroid-free cream. Although no cure exists for psoriasis, treatment can clear psoriatic skin for periods of time. Zithranol-RR contains the active ingredient anthralin, which has been shown to clear psoriasis and keep it in remission for long periods of time with once-daily application.

Dosage Form: 1.2% cream supplied in 15- and 45-g tubes

For More Information: www.eloracpharma.com

Onsolis

Marketed by: Meda Pharmaceuticals Inc (Somerset, NJ)

Indication: The FDA approved Onsolis (fentanyl buccal soluble film), a new dosage form for fentanyl. Onsolis is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The product is available in a small film that sticks to the inside of the patient’s cheek and dissolves within 15 to 30 minutes after it is applied.

Dosage Form: Buccal soluble film in 200-, 400-, 600-, 800-, and 1200- mcg dosage strengths

For More Information: www.onsolis.com

Valcyte

Marketed by: Roche (Nutley, NJ)

Indication: Roche announced that the FDA approved a new pediatric indication in organ transplant patients for Valcyte (valganciclovir hydrochloride)—for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk for developing CMV disease. A new pediatric oral formulation for Valcyte was also approved by the FDA, which will allow easier administration to pediatric patients. Valcyte tablets also are indicated in adult patients for the treatment of CMV retinitis in patients with AIDS, and for the prevention of CMV disease in kidney, heart, and kidney— pancreas transplant patients at high risk.

Dosage Form: Tablets: 450 mg Oral Solution: 50 mg/mL

For More Information: www.rocheusa.com/products/valcyte

www.rochetransplant.com

Norditropin NordiFlex 30 mg/3 mL

Marketed by: Novo Nordisk (Princeton, NJ)

Indication: Novo Nordisk recently announced the availability of the Norditropin (somatropin [rDNA origin] injection) NordiFlex 30 mg/3 mL. The product is the only prefilled, preloaded pen that allows children who need a dose of growth hormone larger than 4.5 mg to take 1 injection instead of 2. The pen holds twice the volume of, and has a higher maximum dose than, the 15-mg Norditropin NordiFlex pen, offering a more convenient option for patients who require a growth hormone dose up to 6.0 mg. Growth hormone deficiency exists when growth hormone, which regulates growth in children, is absent or produced in inadequate amounts.

Dosage Form: Prefilled pen: 30 mg/3 mL

For More Information: www.norditropin-us.com