The following drugs have recently been approved by the FDA for 2006, this
includes newly approved drugs and new indications for drugs already approved
by the FDA:
Ranexa (ranolazine) Extended-Release Tablets
Approved: January 27, 2006 Company: CV Therapeutics, Inc.
Treatment for: Chronic Angina
Ranexa is a novel antianginal and anti-ischemic agent indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs.
Exubera Inhalation Powder
Approved: January 27, 2006 Company: Pfizer Inc
Treatment for: Type 1 and Type 2 Diabetes in Adults
Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs prior to eating, using the handheld Exubera Inhaler. Exubera is indicated for the treatment of adult patients with diabetes mellitus, either as monotherapy, or in combination with oral agents or longer-acting insulins.
Sutent (sunitinib malate) Capsules
Approved: January 26, 2006 Company: Pfizer Inc.
Treatment for: Gastrointestinal Stromal Tumors and Renal Carcinoma
Sutent is one of the first in a new class of drugs that selectively targets multiple protein receptors, called receptor tyrosine kinases (RTKs). Sutent is indicated for the treatment of patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer.
Taclonex (calcipotriene and betamethasone) Ointment
Approved: January 10, 2006 Company: Warner Chilcott/LEO Pharma
Treatment for: Psoriasis
Taclonex is a topical ointment containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of psoriasis vulgaris in adults.
Vivaglobin (immune globulin subcutaneous) Injection
Approved: January 9, 2006 Company: ZLB Behring
Treatment for: Primary Immunodeficiencies
Vivaglobin is a subcutaneous immunoglobulin (Ig) replacement therapy for treating patients with primary immunodeficiencies (PI).
Boniva IV (ibandronate sodium) Injection
Approved: January 6, 2006 Company: Roche/GlaxoSmithKline
Treatment for: Postmenopausal Osteoporosis
Boniva Injection is an intravenous formulation of the bisphosphonate drug ibandronate sodium, administered quarterly for the treatment of postmenopausal osteoporosis.
Climara Pro (estradiol/levonorgestrel) Transdermal System
First Approved: November 21, 2003 Company: Berlex, Inc.
Treatment for: Menopausal Vasomotor Symptoms
Climara Pro is a once-a-week, combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
New Indication Approved: January 4, 2006
Treatment for: Prevention of Postmenopausal Osteoporosis
Climara Pro is now also approved for the prevention of postmenopausal osteoporosis.