Rx Product News

Pharmacy Times, Volume 0, 0

Cymbalta

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

Indication:February 26, 2007—Eli Lillyand Co announced that theFDA approved the antidepressantCymbalta (duloxetine hydrochloride) for the treatmentof generalized anxiety disorder (GAD). GAD isdefined in the Diagnostic and Statistical Manual ofMental Disorders, Fourth Edition, as excessive anxietyand worry, present more days than not, for at least 6months. It must be associated with at least 3 of thefollowing 6 symptoms: restlessness or feeling keyedup or on edge, being easily fatigued, difficulty concentratingor mind going blank, irritability, muscle tension,and/or sleep disturbance. Cymbalta is a member ofthe class of drugs referred to as serotonin and norepinephrinereuptake inhibitors. Cymbalta is also indicatedfor the treatment of major depressive disorder andthe management of neuropathic pain associated withdiabetic peripheral neuropathy.

Dosage form:Delayed-release capsules: 20, 30, and 60 mg

For more information:www.cymbalta.com800-LillyRx (800-545-5979)

HumaPen Memoir

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

Indication:February 22, 2007—HumaPen Memoir, a newreusable insulin pen, to beused only with Humalog(insulin lispro injection [rDNA origin]), was introducedby Eli Lilly and Co. Humalog is an insulin analog that isindicated in the treatment of patients with diabetesmellitus for the control of hyperglycemia. The newHumaPen is the world's first insulin pen that actually"remembers" multiple insulin doses. Memoir automaticallyrecords the time, date, and amount of the last 16insulin doses and the priming doses, which may helppatients with diabetes simplify the daily managementof their disease and help clinicians develop a treatmentplan. Patients can dial a dose 1 unit at a time; if apatient dials too many doses, he or she can correctthe dose without wasting any insulin.

Dosage form:For use with Humalog 3-mL insulin cartridges (100 IU/mL)

For more information:www.humalog.com800-LillyRx (800-545-5979)

Humira

Marketed by:Abbott(Abbott Park, Ill)

Indication:February 27, 2007—Abbottannounced that it received FDAapproval to market Humira(adalimumab) as a treatmentfor reducing the signs andsymptoms and inducing and maintaining clinicalremission in adults with moderate-to-severe activeCrohn's disease who have had an inadequateresponse to conventional therapy. This approval establishesHumira as the first and only self-administeredbiologic for the treatment of Crohn's disease. No medicalor surgical cure exists for the disease, and fewoptions are available for patients with this chroniccondition. In addition to this new indication, Humira isthe only fully human monoclonal antibody approvedfor the treatment of rheumatoid arthritis, psoriaticarthritis, and ankylosing spondylitis.

Dosage form:Single-use pen or single-use prefilled glass syringe: 40mg/0.8 mL

For more information:www.humira.com800-633-9110

Lipitor

Marketed by:Pfizer Inc(New York, NY)

Indication:March 7, 2007—Pfizer announced that Lipitor (atorvastatin calcium)received FDA approval for 5 new indications inpatients with heart disease—to reduce the risk ofnonfatal heart attacks, fatal and nonfatal strokes, certaintypes of heart surgery, hospitalization for heartfailure, and chest pain in patients with heart disease.Lipitor is the first cholesterol-lowering medication tobe approved by the FDA for the reduction of the riskof hospitalization for heart failure. The use of Lipitorhas been expanded to patients at high risk for cardiovascularevents because of established heart disease;it was previously approved to reduce cardiovascularevents in patients without heart disease.

Dosage form:Tablets: 10, 20, 40, and 80 mg

For more information:www.lipitor.com800-879-3477

Tekturna

Marketed by:NovartisPharmaceuticals Corp(East Hanover, NJ)

Indication:March 6, 2007—Novartis announced that the FDAhas approved Tekturna (aliskiren), the first new typeof medicine in more than 10 years for treating highblood pressure, a condition that affects an estimated1 billion people worldwide and is still uncontrolled innearly 70% of patients. The United States is the firstcountry in the world to approve Tekturna. A oncedailyoral therapy, Tekturna is the first in a new classof drugs known as direct renin inhibitors, targetingthe enzyme renin that is responsible for triggering aprocess that can contribute to high blood pressure.The product acts at the beginning of the blood pressure-regulation process, while other available highblood pressure medications act at later stages.

Dosage form:Tablets: 150 and 300 mg

For more information:www.tekturna.com888-Tekturna (888-835-8876)

Néevo

Marketed by:Pan American Laboratories/Pamlab LLC (Covington, La)

Indication:January 9, 2007—Pamlab LLCannounced the introduction ofNéevo (includes 1 mg of L-methylfolate)prenatal vitamins. This productis a medical food in caplet form andis indicated for the distinct nutritionalrequirements of those womenunder a physician's treatment for vitamin deficiencythroughout pregnancy and the postnatal period (forboth lactating and nonlactating mothers), with particularemphasis for those individuals who have or are atrisk for folate deficiencies or 677CT polymorphism;and/or women older than 35 years of age who areassociated with higher-risk pregnancies. Néevo can beused prior to conception to improve nutritional status.

Dosage form:One caplet daily

For more information:www.neevoprenatal.com

Vyvanse

Marketed by:Shire plc(Philadelphia,Pa) and NewRiver Pharmaceuticals Inc (Radford, Va)

Indication:February 23, 2007—Shire plc and its collaborativepartner New River Pharmaceuticals Inc announcedthat the FDA granted marketing approval for Vyvanse(lisdexamfetamine dimesylate; formerly known asNRP104) for the treatment of attention-deficit/hyperactivitydisorder (ADHD). Vyvanse is the first and onlystimulant prodrug to receive FDA approval for thetreatment of ADHD. It remains therapeutically inactiveuntil metabolized in the body.

Dosage form:Capsules: 30, 50, and 70 mg

For more information:www.shireadhdtreatments.com800-536-7878

Yaz

Marketed by:Berlex Inc (Wayne, NJ), a US affiliate ofBayer Schering Pharma, Germany

Indication:January 29, 2007—The FDA approved anew indication for Yaz (3 mg drosperinone/20 mcgethinyl estradiol) to treat moderate acne vulgaris, oneof the most common skin disorders in the UnitedStates, in women who desire an oral contraceptive forbirth control. With this additional indication, Yaz is thefirst and only oral contraceptive ever approved by theFDA for 3 distinct indications. It was previouslyapproved as an oral contraceptive (March 2006) andas a treatment for the emotional and physical symptomsof premenstrual dysphoric disorder (October2006).

Dosage form:Tablets: blister pack containing 24 active tablets (3 mgdrospirenone/20 mcg ethinyl estradiol) and 4 inerttablets

For more information:www.yaz-us.com888-BERLEX-4 (888-237-5394)