Pharmacy Times

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ACAM2000


Marketed by:
Acambis plc (Cambridge, UK, and Cambridge, Mass)

Indication:
August 31, 2007—The FDA approved Acambis plc's ACAM2000 (Smallpox [Vaccinia] Vaccine, Live) vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is supplied as a single-dose vaccine administered percutaneously. It is made using a pox virus called vaccinia, which is related to but different from the virus that causes smallpox. The vaccine contains live vaccinia virus and works by causing a mild infection that stimulates an immune response that effectively protects against smallpox without actually causing the disease. Acambis developed ACAM2000 under contracts with the US Centers for Disease Control and Prevention (CDC) as part of its preparations for a public health emergency.

Dosage Form:
Lyophilized powder reconstituted with packaged diluent. After reconstitution, each vial has approximately 100 doses of 0.0025 mL of live vaccinia virus containing 2.5-12.5 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 that the FDA approved Evista (raloxifene HCl), its osteoporosis drug, for a new use to reduce the risk of invasive breast cancer in 2 populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. Evista, a selective estrogen receptor modulator (recently classified by the FDA as an estrogen agonist/antagonist), is already approved for the prevention and treatment of osteoporosis in postmenopausal women. Evista represents 1 treatment option that can help address 2 leading health concerns—osteoporosis and invasive breast cancer. The American Cancer Society estimates that approximately 180,000 women are diagnosed 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 Nordisk announced that the FDA approved Norditropin (somatropin [rDNA origin] injection) for the treatment of children with short stature associated with Turner syndrome. Turner syndrome is a rare chromosomal condition caused by complete or partial absence of the second sex chromosome (X chromosome) in females. This occurs in approximately 1 in 2500 live female births and in as many as 10% of all miscarriages worldwide. A majority of patients (90%-100% depending on the chromosomal abnormalities) with Turner syndrome have a short stature. Norditropin also is indicated for the treatment of children with short stature associated with Noonan syndrome, for treatment of children with growth failure due to growth hormone deficiency (GHD), and for treatment of adults with 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; 15 mg/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—Endo Pharmaceuticals Inc announced a new appearance for Opana ER (oxymorphone HCl) extendedrelease tablets CII. Opana ER tablets will be changed from an imprinted-tablet appearance to a debossedtablet appearance. Imprinted Opana ER tablets have product markings that are printed in black ink on the surface of each tablet. The new appearance for Opana ER will now have product markings that are pressed into the surface of each 5-, 10-, 20-, and 40-mg tablet. Opana ER is indicated for the relief of moderate-tosevere pain in patients requiring continuous, aroundthe- clock opioid treatment for an extended period of time.

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 CSL Limited

Indication:
September 28, 2007—CSL Biotherapies announced that the FDA approved its influenza virus vaccine, Afluria (influenza virus vaccine). Afluria is intended to protect adults aged 18 and older from influenza type A and type B flu viruses. Each dose contains the required dose of influenza virus hemagglutinin antigens from the influenza strains recommended and prioritized by FDA's Vaccine and Related Biological Products Advisory Committee for the 2007-2008 flu season. Influenza is a contagious respiratory illness that can cause annual epidemics. The vaccine is administered as a single injection in the upper arm and is available in both 0.5-mL single-dose, thimerosal-free, prefilled syringes and 5-mL multidose vials, containing 10 doses, with thimerosal, a mercury 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 Therapeutics announced the FDA approval and launch of the 1000-mg tablet formulation of Ranexa (ranolazine extended- release tablets). The approved product labeling recommends that Ranexa be initiated at 500 mg bid and increased to 1000 mg bid, as needed, based on clinical symptoms. Previously, patients who were taking 1000 mg bid had to take four 500-mg tablets per day. These patients now have the option of taking two 1000-mg tablets per day. Ranexa is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, 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 FDA approved a new, higher-dose strength of Stalevo (carbidopa, levodopa,and entacapone), according to Novartis Pharmaceuticals Corp. Stalevo is indicated for Parkinson's disease patients with signs and symptoms of end-of-dose "wearing off." Stalevo is now available in a 200-mg dose (50 mg carbidopa, 200 mg levodopa, and 200 mg entacapone), which provides greater dosing flexibility in the treatment of Parkinson's disease patients and may lessen the burden of managing multiple medications among patients and their caregivers. Stalevo is approved to substitute immediate-release carbidopa/levodopa and entacapone previously administered as individual products, or to replace immediate-release carbidopa/levodopa therapy, without entacapone, in certain Parkinson's disease patients who are experiencing the signs and symptoms of end-of-dose wearing off.

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?Quinnova Pharmaceuticals announced the introduction of Tersi Foam (selenium sulfide in a waterand lipid-based foam, 2.25%), which is indicated for the treatment of seborrheic dermatitis and tinea versicolor. Tersi Foam, an antiseborrheic, antifungal preparation, is applied topically for the treatment of seborrheic dermatitis and tinea versicolor of the skin, combining Proderm Technology with the effectiveness of selenium sulfide 2.25%. Proderm Technology is a water?lipid-based foam that mimics the water?lipidbased structure of the skin.

Dosage Form:
70-g aerosolized canister

For More Information:
866-210-1129
www.quinnova.com