Rx Product News: January 2009
Gardasil
Marketed by:
Merck & Co (Whitehouse Station, NJ)
Indication:
September 12, 2008—TheFDA approved Gardasil(human papillomavirusquadrivalent [types 6, 11, 16, and 18] vaccine,recombinant) for the prevention of 2 additionalcancers—vulvar and vaginal cancers caused byHPV types 16 and 18. Gardasil is now approved forthe prevention of cervical, vulvar, and vaginal cancerscaused by HPV types 16 and 18; genital wartscaused by HPV types 6 and 11; and precancerousor dysplastic lesions caused by HPV types 6, 11, 16,and 18 in girls and young women aged 9 through26. It is estimated that HPV types 16 and 18 accountfor 40% to 50% of vulvar cancers, 70% of vaginalcancers, 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:
Aczone Gel 5%
Marketed by:
Allergan Inc (Irvine, CA)
Indication:
November 17, 2008—AllerganInc announced the nationwideavailability of Aczone (dapsone)Gel 5%, a new, first-in-class topicaltreatment for inflammatoryacne. Dapsone is the first newmolecule in a decade approvedby the FDA for the topical treatment of acne vulgaris,and Aczone Gel 5% combines dapsone in a SolventMicroparticulate gel, enabling dapsone to be appliedtopically. It is approved for patients 12 and older, andmay be used beyond the face. Patients should applya pea-size drop in a thin layer on the affected area,twice daily.
Dosage Form:
30-g tube
For More Information:
Apidra
Marketed by:
Sanofi-aventis (Bridgewater, NJ)
Indication:
October 29, 2008—Sanofiaventisannounced the FDAapproval of Apidra (insulinglulisine [rDNA origin] injection)to improve glycemiccontrol in children 4 yearsof age and older with diabetes mellitus. Apidra has arapid onset and short duration of action and shouldnormally be used in combination with a longer-actingor basal insulin. It can be administered using aninsulin infusion pump, vial and syringe, the OptiClikreusable pen, or intravenously under proper medicalsupervision in a clinical setting. It also is indicated foradults with type 1 and type 2 diabetes for the controlof high blood sugar.
Dosage Form:
Apidra 100 units/mL is available as: 10-mL vials and3-mL cartridge system for use in OptiClik (InsulinDelivery Device)
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Humalog and Humulin
Marketed by:
Eli Lilly and Co (Indianapolis, IN)
Indication:
October 27, 2008—Eli Lilly and Co announced theintroduction of a color differentiation system forU-100 insulin products marketed in the United States,including vials, pens, and individual packaging forHumalog (insulin lispro injection [rDNA origin]) andHumulin (regular insulin human injection, USP [rDNAorigin]). The Lilly color differentiation system followsthe introduction of bar coding of packaging and insulinvials instituted in the United States by Lilly in 2004.These safety measures offer patients, physicians,pharmacists, and other health care professionals amultitiered product identification and recognitionsystem for Lilly's insulin products. Colors indicateboth insulin family and insulin type: burgundy for theHumalog family, blue for the Humulin family, and yellowfor Regular insulin. The Humalog brand of insulinsis indicated for use in patients with diabetes to controlhigh blood sugar.
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Promacta
Marketed by:
GlaxoSmithKline (Philadelphia, PA)
Indication:
November 20, 2008—GlaxoSmithKline announced thatthe FDA granted accelerated approval for Promacta(eltrombopag) for thetreatment of thrombocytopeniain patients withchronic immune (idiopathic)thrombocytopenicpurpura (ITP) whohave had an insufficient response to corticosteroids,immunoglobulins, or splenectomy. Chronic ITP is adisorder marked by increased platelet destruction and/or inadequate platelet production in the blood, whichcauses an increased risk of bruising and bleeding.
Dosage Form:
Tablets: 25- and 50-mg tablets
For More Information:
877-9-PROMACTA
Stalevo
Marketed by:
Novartis Pharmaceuticals Corp (East Hanover, NJ)
Indication:
October 28, 2008—Novartis PharmaceuticalsCorp announced that the FDA approved 2 new dosagestrengths of Stalevo (carbidopa, levodopa, and entacapone)and it subsequently launched the new dosagestrengths. Stalevo is indicated for certain individualswith 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 mgentacapone, and 31.25 mg carbidopa, 125 mg levodopa,and 200 mg entacapone, respectively) providesadded dosing flexibility that enable more customizedapproaches to treating people with Parkinson's diseasein the United States.
Dosage Form:
Tablets: Stalevo 50, 75, 100, 125, 150, and 200 tablets
For More Information:
