Drug Topics - December 12, 2008 - (Page 50)

Product Updates WHAT’S NEW RX & OTC New Products RX CARE New Drugs Sirion Therapeutics Inc. recently announced that Durezol (difluprednate ophthalmic emulsion) 0.05 percent is now available. Durezol, which was approved by the U.S. Food and Drug Administration (FDA) in June, is a topical ophthalmic corticosteroid indicated for the treatment of inﬂammation and pain associated with ocular surgery. Durezol is the ﬁrst, and so far the only, steroid approved for treatment of both inﬂammation and pain. Visit www.durezol. com for more information. New Indications AstraZeneca announced the FDA has approved once-daily Seroquel XR (quetiapine fumarate) Extended-ReleaseTablets for the acute treatment of depressive episodes associated with bipolar disorder and manic and mixed episodes associated with bipolar one disorder, and as maintenance treatment of bipolar one disorder as adjunctive therapy to lithium or divalproex. Seroquel XR is the ﬁrst medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder. Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition with recurring episodes of depression and mania. Approximately 8 million American adults may be affected by bipolar disorder. Visit http:// www.astrazeneca-us.com for more information. The FDA has granted Prezista (darunavir) tablets, a protease inhibitor, approval for an expanded indication for once-daily dosing as part of HIV combination therapy in treatment-naive adults (those who have never taken HIV medication before). The FDA also granted traditional (full) approval to Prezista for twice-daily use in treatment-experienced adult patients. Prezista is marketed in the United States 2 1 by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. Following this new approval, Prezista, co-administered with 100 mg ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeﬁciency virus (HIV-1) infection. Visit http://www.jnj.com for more information. for more information. OTC TriDerma MD has introduced four new skin-care products. They include TriDerma MD Eczema Fast Healing [1] to provide relief for itchy, dry, red, irritated skin; TriDerma MD Extreme Dryness Plus, a formula for severely cracked, dry, damaged skin; TriDerma MD Facial Redness Repair, a botanical formula with Vitamin K and medical-strength ingredients that help reduce redness from sensitivities or rosacea; and TriDerma MD Psoriasis Control, a formula to help heal red, irritated, dry, scaly skin. Visit www.triderma.com for more information. Boiron is launching Children’s Oscillococcinum for flulike symptoms and Children’s Coldcalm for colds. These homeopathic medicines do not contain any of the ingredients under scrutiny by the FDA for use in youngsters; their active ingredients are microdoses of natural ingredients. Visit www.boironusa for more information. New Generics Teva Pharmaceutical Industries Ltd. announced that the FDA has granted approval for the company’s ANDA for Fentanyl Transdermal System, 25 mcg per hour, 50 mcg per hour, 75 mcg per hour and 100 mcg per hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic. The product uses a proprietary matrix design that incorporates the drug into the adhesive. It is indicated for the management of persistent moderate-to-severe chronic pain that requires continuous, aroundthe-clock opioid administration for an extended period of time and that cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids. Contact www.tevapharm.com ETC Blistex introduces Deep Renewal [2], an anti-aging product that reduces deep W W W.D R U GTO P I C S .C O M 50 DRUG TOPICS DEC. 15, 2008 COURTESY OF TRIDERMA (1), BLISTEX (2) http://www.durezol.com http://www.durezol.com http://www.jnj.com http://www.triderma.com http://www.astrazeneca-us.com http://www.astrazeneca-us.com http://www.boironusa.com http://www.tevapharm.com http://WWW.DRUGTOPICS.COM

Table of Contents Feed for the Digital Edition of Drug Topics - December 12, 2008

Drug Topics - December 12, 2008 Contents Up Front Up Front In Depth Letters Health-System Edition Cover Story: Controlled Substance Disposal a Growing Problem for Hospitals Pharmacists Hope for Speedy Approvals Deaths from C. Difficile Increasing PharmMD Teams with HealthSpring RX Care Commentary Ohio Hospital Automates Pharmacy The Business Outlook for 2009 OTC The Pharmacist's Duty to Warn: Implications for Pharmacy Practice New Products Viewpoint

Drug Topics - December 12, 2008

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