Rx Product News

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Aczone Gel 5%

Marketed by:
Allergan Inc (Irvine, CA)

Indication:
July 14, 2008—Allergan Sales, LLC, a wholly owned subsidiary of Allergan Inc, and QLT USA Inc, a wholly owned subsidiary of QLT Inc, announced the completion of Allergan's acquisition of QLT's Aczone (dapsone) Gel 5% product, a topical treatment for acne vulgaris. Aczone Gel is an aqueous topical gel formulation containing 5% dapsone. Combining dapsone in a Solvent Microparticulate gel enables dapsone to be applied topically and safely. Aczone should be applied twice daily—a pea-sized amount should be applied in a thin layer to the acneaffected area.

Dosage Form:
Aczone (dapsone) Gel 5%, available commercially in 30-g laminate tube (professional samples available in 3-g laminate tube)

For More Information:
www.allergan.com



Aloxi Capsules

Marketed by:
Eisai Corp of North America (Woodcliff Lake, NJ)

Indication:
August 23, 2008—Eisai Corp of North America and its partner Helsinn Healthcare SA announced that the FDA approved a new oral formulation of Aloxi (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Aloxi Capsules 0.5 mg for oral administration are indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5-mg capsule is administered approximately 1 hour prior to the start of chemotherapy. Aloxi injection 0.25 mg, a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, has been available in the United States for intravenous administration since 2003.

Dosage Form
: Capsules: 0.5 mg; Injection: 0.25 mg/5 mL and 0.075mg/1.5 mL (free base) single-use vials

For More Information:
www.ALOXI.com



Alvesco HFA

Marketed by:
Sepracor Inc (Marlborough, MA)

Indication:
September 8, 2008—Sepracor Inc announced the avaibility of Alvesco (ciclesonide) HFA Inhalation Aerosol MDI (metered-dose inhaler) by prescription in the United States. Alvesco HFA is a new inhaled corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. It is available in 80 mcg/actuation and 160 mcg/actuation dosage strengths. Alvesco HFA contains the active ingredient ciclesonide, a unique corticosteroid prodrug that is activated into desciclesonide after oral inhalation and which has potent anti-inflammatory activity.

Dosage Form:
Inhalation: 80 and 160 mcg/actuation

For More Information:
www.alvesco.us



Cancidas

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

Indication:
August 5, 2008—Merck & Co Inc announced that the FDA has approved an expanded label for Cancidas (caspofungin acetate), which makes it the first and only echinocandin therapy approved in the United States for the treatment of pediatric patients aged 3 months to 17 years with indicated fungal infections. Cancidas is now indicated in adults and pediatric patients aged 3 months and older for empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and Candida infections, such as intra-abdominal abscesses, peritonitis, and pleural space infections; treatment of esophageal candidiasis; and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.

Dosage Form:
50 and 70 mg

For More Information:
www.merck.com



Keppra XR

Marketed by:
UCB (Brussels, Belgium)

Indication:
September 15, 2008—UCB announced that the FDA approved Keppra XR (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for individuals with partial-onset seizures who are 16 years of age and older. The goal of therapy with antiepileptic drugs (AEDs) is freedom from seizures and minimal side effects. Although many individuals with epilepsy are successfully treated with one or more of the currently available AEDs, a significant percentage still live with uncontrolled seizures or intolerable side effects. The immediate-release tablet form of Keppra was first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Dosing must be individualized according to the patient's renal function state.

Dosage Form:
Tablets: 500 mg

For More Information:
866-822-0068
www.KeppraXR.com



Sancuso

Marketed by:
ProStrakan Group plc (Bedminster, NJ)

Indication:
September 15, 2008—ProStrakan Group plc announced that the FDA approved Sancuso (granisetron transdermal system), the first and only patch to provide up to 5 consecutive days of control of nausea and vomiting for patients receiving a moderately and or highly nausea-inducing chemotherapy regimen. If left untreated, chemotherapy-induced nausea and vomiting can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment, in addition to its social and emotional side effects. Sancuso is a transdermal system, or skin patch, that delivers granisetron, its active component and an established inhibitor of nausea and vomiting, through a thin layer of adhesive that attaches the patch to the skin.

Dosage Form:
52-cm2 patch containing 34.3 mg of granisetron delivering 3.1 mg per 24 hours

For More Information:
www.ProStrakan-USA.com


PrandiMet

Marketed by:
Novo Nordisk Inc (Princeton, NJ) and Sciele Pharma Inc (Atlanta, GA)

Indication:
June 24, 2008—Novo Nordisk Inc and Sciele Pharma Inc announced that the FDA approved PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and the insulin sensitizer, metformin, for the treatment of type 2 diabetes. PrandiMet has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.

Dosage Form:
Tablets: 1 mg repaglinide/500 mg metformin HCl; 2 mg repaglinide/500 mg metformin HCl

For More Information: www.prandimet.com


Viread

Marketed by:
Gilead Sciences Inc (Foster City, CA)

Indication:
August 11, 2008—Gilead Sciences announced that the FDA granted marketing approval for Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B, a serious liver disease caused by the hepatitis B virus (HBV). Viread is administered as a once-daily tablet and works by blocking HBV DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells.

Dosage Form:
Tablets: 300 mg

For More Information:
800-GILEAD-5 (800-445-3235)
www.viread.com

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