Rx Product News

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Gardasil

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

Indication:
September 12, 2008—The FDA approved Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant) for the prevention of 2 additional cancers—vulvar and vaginal cancers caused by HPV types 16 and 18. Gardasil is now approved for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18 in girls and young women aged 9 through 26. It is estimated that HPV types 16 and 18 account for 40% to 50% of vulvar cancers, 70% of vaginal cancers, and 70% of all cases of cervical cancer.

Dosage Form:
0.5-mL suspension for injection as a single-dose vial and prefilled syringe

For More Information:
www.gardasil.com


Aczone Gel 5%

Marketed by:
Allergan Inc (Irvine, CA)

Indication:
November 17, 2008—Allergan Inc announced the nationwide availability of Aczone (dapsone) Gel 5%, a new, first-in-class topical treatment for inflammatory acne. Dapsone is the first new molecule in a decade approved by the FDA for the topical treatment of acne vulgaris, and Aczone Gel 5% combines dapsone in a Solvent Microparticulate gel, enabling dapsone to be applied topically. It is approved for patients 12 and older, and may be used beyond the face. Patients should apply a pea-size drop in a thin layer on the affected area, twice daily.

Dosage Form:
30-g tube

For More Information:
www.allergan.com



Apidra

Marketed by:
Sanofi-aventis (Bridgewater, NJ)

Indication:
October 29, 2008—Sanofiaventis announced the FDA approval of Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children 4 years of age and older with diabetes mellitus. Apidra has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. It can be administered using an insulin infusion pump, vial and syringe, the OptiClik reusable pen, or intravenously under proper medical supervision in a clinical setting. It also is indicated for adults with type 1 and type 2 diabetes for the control of high blood sugar.

Dosage Form:
Apidra 100 units/mL is available as: 10-mL vials and 3-mL cartridge system for use in OptiClik (Insulin Delivery Device)

For More Information:
www.apidra.com



Humalog and Humulin

Marketed by:
Eli Lilly and Co (Indianapolis, IN)

Indication:
October 27, 2008—Eli Lilly and Co announced the introduction of a color differentiation system for U-100 insulin products marketed in the United States, including vials, pens, and individual packaging for Humalog (insulin lispro injection [rDNA origin]) and Humulin (regular insulin human injection, USP [rDNA origin]). The Lilly color differentiation system follows the introduction of bar coding of packaging and insulin vials instituted in the United States by Lilly in 2004. These safety measures offer patients, physicians, pharmacists, and other health care professionals a multitiered product identification and recognition system for Lilly's insulin products. Colors indicate both insulin family and insulin type: burgundy for the Humalog family, blue for the Humulin family, and yellow for Regular insulin. The Humalog brand of insulins is indicated for use in patients with diabetes to control high blood sugar.

For More Information:
www.lilly.com



Promacta

Marketed by:
GlaxoSmithKline (Philadelphia, PA)

Indication:
November 20, 2008—GlaxoSmithKline announced that the FDA granted accelerated approval for Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Chronic ITP is a disorder marked by increased platelet destruction and/ or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.

Dosage Form:
Tablets: 25- and 50-mg tablets

For More Information:
877-9-PROMACTA
www.PROMACTACARES.com



Stalevo

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

Indication:
October 28, 2008— Novartis Pharmaceuticals Corp announced that the FDA approved 2 new dosage strengths of Stalevo (carbidopa, levodopa, and entacapone) and it subsequently launched the new dosage strengths. Stalevo is indicated for certain individuals with Parkinson's disease who experience end-of-dose "wearing off." The approval of Stalevo 75 and 125 tablets (18.75 mg carbidopa, 75 mg levodopa, and 200 mg entacapone, and 31.25 mg carbidopa, 125 mg levodopa, and 200 mg entacapone, respectively) provides added dosing flexibility that enable more customized approaches to treating people with Parkinson's disease in the United States.

Dosage Form:
Tablets: Stalevo 50, 75, 100, 125, 150, and 200 tablets

For More Information:
www.stalevo.com


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