Marketed by: Janssen Pharmaceuticals (Titusville, NJ)
Indication: The FDA approved Xarelto (rivaroxaban), a novel, once-daily oral anticoagulant for the prophylaxis of deep vein thrombosis that may lead to pulmonary embolism in patients undergoing hip or knee replacement surgery. It is recommended that patients undergoing hip replacement continue treatment for 35 days and patients undergoing knee replacement continue treatment for 12 days. A factor Xa inhibitor, Xarelto carries a boxed warning to consider the risk of epidural or spinal hematomas in patients taking anticoagulants who receive neuraxial anesthesia or undergo spinal puncture. Use of Xarelto should be avoided in patients with severe renal impairment or moderate or severe hepatic impairment. The dosage for Xarelto is 10 mg once daily taken with or without food.
Dosage Form: Tablets: 10 mg
For More Information: www.xareltohcp.com
Marketed by: Novartis (East Hanover, NJ)
Indication: Novartis announced the FDA approval of Arcapta Neohaler (indacaterol inhalation powder), a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is the only once-daily LABA currently approved for this indication. Arcapta Neohaler is not indicated for the treatment of acute deteriorations of COPD or asthma. Like all LABAs, Arcapta Neohaler carries a boxed warning against the risk of asthmarelated death. Arcapta capsules are for oral inhalation only, and should be not be swallowed. The product will be available in the United States in the first quarter of 2012.
Dosage Form: Inhalation powder hard capsules: 75 mcg
For More Information: www.novartis.com
Marketed by: Archimedes Pharma Ltd (Bedminster, NJ)
Indication: The FDA approved Lazanda (fentanyl) nasal spray, an opioid analgesic indicated for the management of breakthrough pain in cancer patients 18 years and older who are already receiving but are tolerant to opioid therapy for underlying, persistent cancer pain. The initial dose for all patients is 100 mcg. Patients should wait at least 2 hours before treating another episode of breakthrough pain with Lazanda. Lazanda will be available in the second half of 2011 with a Risk Evaluation and Mitigation Strategy designed to minimize the risk of misuse, abuse, overdose, addiction, and serious complications.
Dosage Form: Nasal spray: each spray delivers 100 mcL of solution containing either 100 mcg or 400 mcg fentanyl base
For More Information: www.lazanda.com
Marketed by: Abbott (Abbott Park, IL)
Indication: Abbott announced the FDA approval of a 45-mg strength, 6-month administration formulation of Lupron Depot (leuprolide acetate for depot suspension), a gonadotropinreleasing hormone agonist indicated for the palliative treatment of advanced prostate cancer. Lupron Depot suppresses the production of testosterone, which can help slow or stop the growth of hormone-dependent cancer cells, and may relieve pain and other symptoms of prostate cancer. The drug was previously approved in a 22.5-mg strength for 3-month administration and a 30-mg strength for 4-month administration.
Dosage Form: Intramuscular injection: 22.5, 30, and 45 mg injections in a kit with a prefilled dual chamber syringe
For More Information: www.lupron.com
Zutripro Oral Solution
Marketed by: Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical Inc (Madison, MS)
Indication: Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine HCl) Oral Solution (CIII) received FDA approval for the relief of cough and nasal congestion associated with common cold and for the relief of upper respiratory allergy symptoms, including nasal congestion, in adults 18 years and older. The recommended dose of Zutripro is 5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours. To prevent dosing errors, pharmacists should provide patients taking Zutripro with an accurate milliliter dosing device and instructions for measuring a correct dose.
Dosage Form: Oral solution: each 5-mL dose contains hydrocodone bitartrate, USP, 5 mg; chlorpheniramine maleate, USP, 4 mg; and pseudoephedrine hydrochloride, USP, 60 mg
For More Information: www.hawthornrx.com
Marketed by: Vertex Pharmaceuticals Inc (Cambridge, MA)
Indication: The FDA approved Incivek (telaprevir) tablets, indicated in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. It is approved for patients who are new to treatment and for those who were treated previously but who did not achieve a viral cure. Incivek is given for 12 weeks in combination with peginterferon alfa and ribavirin, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin alone. The dosage for Incivek is 750 mg taken 3 times a day with food containing approximately 20 grams of fat.
Dosage Form: Tablets: 750 mg
For More Information: www.vrtx.com
Marketed by: GlaxoSmithKline Biologicals (Rixensart, Belgium)
Indication: GlaxoSmithKline announced the FDA approval of Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed) for the prevention of tetanus, diphtheria, and pertussis in patients 65 years and older. Boostrix was initially approved in 2005 for adolescents aged 10 to 18 years, then again in 2008 for adults aged 19 to 64 years. With the expanded indication, Boostrix is the first to offer older patients protection from all 3 diseases in a single-dose booster shot.
Dosage Form: Intramuscular injection: single-dose vials and prefilled syringes containing a 0.5-mL suspension for injection
For More Information: www.gsk.com
Neo-Polycin Ophthalmic Ointment USP
Marketed by: Fera Pharmaceuticals, LLC (New York, NY)
Indication: Fera Pharmaceuticals announced the launch of Neo-Polycin (neomycin and polymyxin B sulfates and bacitracin zinc) Ophthalmic Ointment USP. Neo-Polycin is an antimicrobial indicated for the topical treatment of external ocular infections, including conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis. Neo-Polycin may be applied every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. To prevent contamination of the dispensing container, patients should be advised to avoid allowing the tip of the tube to contact the eye, eyelid, fingers, or any other surface.
Dosage Form: Ophthalmic ointment: 3.5-g sterile, tamper-evident tube
For More Information: www.ferapharma.com