rx PRODUCT news
ACAM2000
Marketed by:
Acambis plc(Cambridge, UK,and Cambridge, Mass)
Indication:
August 31, 2007—The FDA approved Acambis plc'sACAM2000 (Smallpox [Vaccinia] Vaccine, Live) vaccinefor active immunization against smallpox disease forpersons determined to be at high risk for smallpoxinfection. ACAM2000 is supplied as a single-dose vaccineadministered percutaneously. It is made using apox virus called vaccinia, which is related to but differentfrom the virus that causes smallpox. The vaccinecontains live vaccinia virus and works by causing amild infection that stimulates an immune responsethat effectively protects against smallpox withoutactually causing the disease. Acambis developedACAM2000 under contracts with the US Centers forDisease Control and Prevention (CDC) as part of itspreparations for a public health emergency.
Dosage Form:
Lyophilized powder reconstituted with packaged diluent.After reconstitution, each vial has approximately100 doses of 0.0025 mL of live vaccinia virus containing2.5-12.5 x 105 plaque-forming units.
For More Information:
866-440-9440
www.acambis.com
Evista
Marketed by:
Eli Lilly and Co(Indianapolis, Ind)
Indication:
September 14, 2007—Eli Lilly and Co announced thatthe FDA approved Evista (raloxifene HCl), its osteoporosisdrug, for a new use to reduce the risk of invasivebreast cancer in 2 populations: postmenopausalwomen with osteoporosis and postmenopausalwomen at high risk for invasive breast cancer. Evista,a selective estrogen receptor modulator (recentlyclassified by the FDA as an estrogen agonist/antagonist),is already approved for the prevention and treatmentof osteoporosis in postmenopausal women.Evista represents 1 treatment option that can helpaddress 2 leading health concerns—osteoporosis andinvasive breast cancer. The American Cancer Societyestimates that approximately 180,000 women arediagnosed with invasive breast cancer each year.
Dosage Form:
Tablets: 60 mg
For More Information:
www.evista.com
Norditropin
Marketed by:
Novo Nordisk(Princeton, NJ)
Indication:
September 21, 2007—Novo Nordiskannounced that the FDA approved Norditropin (somatropin[rDNA origin] injection) for the treatment of childrenwith short stature associated with Turner syndrome.Turner syndrome is a rare chromosomal conditioncaused by complete or partial absence of thesecond sex chromosome (X chromosome) in females.This occurs in approximately 1 in 2500 live femalebirths and in as many as 10% of all miscarriagesworldwide. A majority of patients (90%-100% dependingon the chromosomal abnormalities) with Turnersyndrome have a short stature. Norditropin also isindicated for the treatment of children with shortstature associated with Noonan syndrome, for treatmentof children with growth failure due to growthhormone deficiency (GHD), and for treatment of adultswith either adult- or childhood-onset GHD.
Dosage Form:
5 mg/1.5 mL: cartridge and Norditropin NordiFlex pen;10 mg/1.5 mL: Norditropin NordiFlex pen only; 15mg/1.5 mL: cartridge and Norditropin NordiFlex pen
For More Information:
888-NOVO-444 (888-668-6444)
www.norditropin-us.com
Opana ER
Marketed by:
Endo Pharmaceuticals Inc(Chadds Ford, Pa)
Indication:
October 1, 2007—EndoPharmaceuticals Incannounced a new appearancefor Opana ER (oxymorphoneHCl) extendedreleasetablets CII. Opana ER tablets will be changedfrom an imprinted-tablet appearance to a debossedtabletappearance. Imprinted Opana ER tablets haveproduct markings that are printed in black ink on thesurface of each tablet. The new appearance for OpanaER will now have product markings that are pressedinto the surface of each 5-, 10-, 20-, and 40-mg tablet.Opana ER is indicated for the relief of moderate-toseverepain in patients requiring continuous, aroundthe-clock opioid treatment for an extended period oftime.
Dosage Form:
Tablets: 5, 10, 20, and 40 mg
For More Information:
800-462-ENDO (800-462-3636)
www.opana.com
Hot Rx
Afluria
Marketed by:
CSL Biotherapies(King of Prussia, Pa),a subsidiary of CSLLimited
Indication:
September 28, 2007—CSL Biotherapies announcedthat the FDA approved its influenza virus vaccine,Afluria (influenza virus vaccine). Afluria is intended toprotect adults aged 18 and older from influenza typeA and type B flu viruses. Each dose contains therequired dose of influenza virus hemagglutinin antigensfrom the influenza strains recommended andprioritized by FDA's Vaccine and Related BiologicalProducts Advisory Committee for the 2007-2008 fluseason. Influenza is a contagious respiratory illnessthat can cause annual epidemics. The vaccine isadministered as a single injection in the upper armand is available in both 0.5-mL single-dose,thimerosal-free, prefilled syringes and 5-mL multidosevials, containing 10 doses, with thimerosal, amercury derivative, as a preservative.
Dosage form:
Single 0.5-mL dose for intramuscular injection
For More Information:
www.afluria.com
Ranexa
Marketed by:
CV Therapeutics(Palo Alto, Calif)
Indication:
August 14, 2007—CV Therapeuticsannounced the FDA approval andlaunch of the 1000-mg tablet formulationof Ranexa (ranolazine extended-release tablets). The approvedproduct labeling recommends thatRanexa be initiated at 500 mg bid andincreased to 1000 mg bid, as needed, based on clinicalsymptoms. Previously, patients who were taking1000 mg bid had to take four 500-mg tablets per day.These patients now have the option of taking two1000-mg tablets per day. Ranexa is indicated for thetreatment of chronic angina in patients who have notachieved an adequate response with other antianginaldrugs, and should be used in combination withamlodipine, beta-blockers, or nitrates.
Dosage Form:
Tablets: 500 and 1000 mg
For More Information:
www.ranexa.com
www.cvt.com
Stalevo
Marketed by:
Novartis Pharmaceuticals Corp(East Hanover, NJ)
Indication:
August 6, 2007—The FDAapproved a new, higher-dosestrength of Stalevo (carbidopa,levodopa,and entacapone),according to NovartisPharmaceuticals Corp. Stalevois indicated for Parkinson's disease patients with signsand symptoms of end-of-dose "wearing off." Stalevo isnow available in a 200-mg dose (50 mg carbidopa,200 mg levodopa, and 200 mg entacapone), whichprovides greater dosing flexibility in the treatment ofParkinson's disease patients and may lessen the burdenof managing multiple medications amongpatients and their caregivers. Stalevo is approved tosubstitute immediate-release carbidopa/levodopa andentacapone previously administered as individualproducts, or to replace immediate-releasecarbidopa/levodopa therapy, without entacapone, incertain Parkinson's disease patients who are experiencingthe signs and symptoms of end-of-dose wearingoff.
Dosage Form:
Tablets: 50, 100, 150, and 200 mg
For More Information:
www.stalevo.com
Tersi Foam
Marketed by:
Quinnova Pharmaceuticals Inc(Newtown, Pa)
Indication:
August 1, 2007?QuinnovaPharmaceuticals announcedthe introduction of Tersi Foam(selenium sulfide in a waterandlipid-based foam, 2.25%), which is indicated forthe treatment of seborrheic dermatitis and tinea versicolor.Tersi Foam, an antiseborrheic, antifungal preparation,is applied topically for the treatment of seborrheicdermatitis and tinea versicolor of the skin, combiningProderm Technology with the effectiveness ofselenium sulfide 2.25%. Proderm Technology is awater?lipid-based foam that mimics the water?lipidbasedstructure of the skin.
Dosage Form:
70-g aerosolized canister
For More Information:
866-210-1129
www.quinnova.com
