Marketed by: Eli Lilly and Co (Indianapolis, Ind)
Indication: February 26, 2007Eli Lilly and Co announced that the FDA approved the antidepressant Cymbalta (duloxetine hydrochloride) for the treatment of generalized anxiety disorder (GAD). GAD is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, as excessive anxiety and worry, present more days than not, for at least 6 months. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance. Cymbalta is a member of the class of drugs referred to as serotonin and norepinephrine reuptake inhibitors. Cymbalta is also indicated for the treatment of major depressive disorder and the management of neuropathic pain associated with diabetic peripheral neuropathy.
Dosage form: Delayed-release capsules: 20, 30, and 60 mg
For more information: www.cymbalta.com 800-LillyRx (800-545-5979)
Marketed by: Eli Lilly and Co (Indianapolis, Ind)
Indication: February 22, 2007HumaPen Memoir, a new reusable insulin pen, to be used only with Humalog (insulin lispro injection [rDNA origin]), was introduced by Eli Lilly and Co. Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. The new HumaPen is the world's first insulin pen that actually "remembers" multiple insulin doses. Memoir automatically records the time, date, and amount of the last 16 insulin doses and the priming doses, which may help patients with diabetes simplify the daily management of their disease and help clinicians develop a treatment plan. Patients can dial a dose 1 unit at a time; if a patient dials too many doses, he or she can correct the dose without wasting any insulin.
Dosage form: For use with Humalog 3-mL insulin cartridges (100 IU/mL)
For more information: www.humalog.com 800-LillyRx (800-545-5979)
Marketed by: Abbott (Abbott Park, Ill)
Indication: February 27, 2007Abbott announced that it received FDA approval to market Humira (adalimumab) as a treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderate-to-severe active Crohn's disease who have had an inadequate response to conventional therapy. This approval establishes Humira as the first and only self-administered biologic for the treatment of Crohn's disease. No medical or surgical cure exists for the disease, and few options are available for patients with this chronic condition. In addition to this new indication, Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Dosage form: Single-use pen or single-use prefilled glass syringe: 40 mg/0.8 mL
For more information: www.humira.com 800-633-9110
Marketed by: Pfizer Inc (New York, NY)
Indication: March 7, 2007Pfizer announced that Lipitor (atorvastatin calcium) received FDA approval for 5 new indications in patients with heart diseaseto reduce the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. Lipitor is the first cholesterol-lowering medication to be approved by the FDA for the reduction of the risk of hospitalization for heart failure. The use of Lipitor has been expanded to patients at high risk for cardiovascular events because of established heart disease; it was previously approved to reduce cardiovascular events in patients without heart disease.
Dosage form: Tablets: 10, 20, 40, and 80 mg
For more information: www.lipitor.com 800-879-3477
Marketed by: Novartis Pharmaceuticals Corp (East Hanover, NJ)
Indication: March 6, 2007Novartis announced that the FDA has approved Tekturna (aliskiren), the first new type of medicine in more than 10 years for treating high blood pressure, a condition that affects an estimated 1 billion people worldwide and is still uncontrolled in nearly 70% of patients. The United States is the first country in the world to approve Tekturna. A oncedaily oral therapy, Tekturna is the first in a new class of drugs known as direct renin inhibitors, targeting the enzyme renin that is responsible for triggering a process that can contribute to high blood pressure. The product acts at the beginning of the blood pressure- regulation process, while other available high blood pressure medications act at later stages.
Dosage form: Tablets: 150 and 300 mg
For more information: www.tekturna.com 888-Tekturna (888-835-8876)
Marketed by: Pan American Laboratories/Pamlab LLC (Covington, La)
Indication: January 9, 2007Pamlab LLC announced the introduction of Néevo (includes 1 mg of L-methylfolate) prenatal vitamins. This product is a medical food in caplet form and is indicated for the distinct nutritional requirements of those women under a physician's treatment for vitamin deficiency throughout pregnancy and the postnatal period (for both lactating and nonlactating mothers), with particular emphasis for those individuals who have or are at risk for folate deficiencies or 677CT polymorphism; and/or women older than 35 years of age who are associated with higher-risk pregnancies. Néevo can be used prior to conception to improve nutritional status.
Dosage form: One caplet daily
For more information: www.neevoprenatal.com
Marketed by: Shire plc (Philadelphia, Pa) and New River Pharmaceuticals Inc (Radford, Va)
Indication: February 23, 2007Shire plc and its collaborative partner New River Pharmaceuticals Inc announced that the FDA granted marketing approval for Vyvanse (lisdexamfetamine dimesylate; formerly known as NRP104) for the treatment of attention-deficit/hyperactivity disorder (ADHD). Vyvanse is the first and only stimulant prodrug to receive FDA approval for the treatment of ADHD. It remains therapeutically inactive until metabolized in the body.
Dosage form: Capsules: 30, 50, and 70 mg
For more information: www.shireadhdtreatments.com 800-536-7878
Marketed by: Berlex Inc (Wayne, NJ), a US affiliate of Bayer Schering Pharma, Germany
Indication: January 29, 2007The FDA approved a new indication for Yaz (3 mg drosperinone/20 mcg ethinyl estradiol) to treat moderate acne vulgaris, one of the most common skin disorders in the United States, in women who desire an oral contraceptive for birth control. With this additional indication, Yaz is the first and only oral contraceptive ever approved by the FDA for 3 distinct indications. It was previously approved as an oral contraceptive (March 2006) and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (October 2006).
Dosage form: Tablets: blister pack containing 24 active tablets (3 mg drospirenone/20 mcg ethinyl estradiol) and 4 inert tablets
For more information: www.yaz-us.com 888-BERLEX-4 (888-237-5394)