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JevtanaMarketed by:
Sanofi-aventis (Bridgewater, NJ)
Indication:
Sanofi-aventis announced that, after a priority review, the FDA granted marketing authorization for Jevtana (cabazitaxel) Injection, a microtubule inhibitor, in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana 25 mg/m2 is administered every 3 weeks as a 1-hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout Jevtana treatment.
Dosage Form:Single-use vial 60 mg/1.5 mL, supplied with diluent (5.7 mL) for Jevtana
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DaytranaMarketed by:
Shire plc (Philadelphia, PA)
Indication: The FDA granted approval of Daytrana (methylphenidate transdermal system) CII for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already approved by the FDA for the treatment of ADHD in children 6 to 12 years. The product is a transdermal patch that is applied to intact skin and delivers methylphenidate through the blood into the bloodstream. It is recommended that the patch be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg.
Dosage Form:
Transdermal patch: 10, 15, 20, and 30 mg
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Merck & Co Inc (Whitehouse Station, NJ)
Indication:
The FDA approved Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. Dulera combines an inhaled corticosteroid (ICS; mometasone furoate) with a long-acting beta2-agonist (LABA; formoterol fumarate). Because LABAs increase the risk of asthma-related death, Dulera should only be used for patients not adequately controlled on a long-term asthma medication or whose disease severity warrants initiation of treatment with both an ICS and LABA.
Dosage Form:
Inhalation aerosol containing a combination of mometasone furoate (100 or 200 mcg) and formoterol fumarate dihydrate (5 mcg) per actuation
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Exalgo New Beginning KitMarketed by:
Covidien (Mansfield, MA)
Indication:
Covidien recently introduced a New Beginning Kit for EXALGO (hydromorphone HCI) Extended-Release Tablets (CII). EXALGO is an opioid agonist indicated for once-daily administration for the management of moderate-to-severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The product is not intended for use as an as-needed analgesic. Because it is critically important for pain patients to take their medication at the right time, Covidien is providing new patients with a dose alert timer. In addition, Covidien is providing a “Welcome to EXALGO” brochure, important information about safe use of EXALGO, a pain diary, and an introductory video for patients.
Dosage Form:
Tablets: 8, 12, or 16 mg
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LucentisMarketed by:
Genentech Inc (South San Francisco, CA)
Indication:
Genentech Inc, a member of the Roche Group, announced that the FDA approved Lucentis (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion. The FDA approved this new indication after a 6-month priority review. Lucentis is a vascular endothelial growth factor inhibitor that was first approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration in 2006.
Dosage Form:
10 mg/mL solution in a single-use vial for intravitreal injection
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OLEPTROMarketed by:
Angelini Labopharm (Princeton, NJ)
Indication:
Labopharm Inc announced that the FDA approved Oleptro (trazodone hydrochloride) Extended-release tablets, a novel oncedaily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD). MDD is a common mental illness, affecting more than 14 million US adults, and is often characterized by a combination of social and somatic symptoms. Oleptro uses Labopharm’s unique Contramid technology to control the release of trazodone versus active substances in oral medications, whether taken whole or as a split dose. Oleptro is marketed in the United States by the recently formed joint venture Angelini Labopharm.
Dosage Form:
Tablets: 150 and 300 mg
For More Information:www.oleptro.com
NasonexMarketed by:
Merck & Co Inc (Whitehouse Station, NJ)
Indication:
Merck & Co Inc recently announced a new indication for their corticosteroid allergy treatment, Nasonex (mometasone furoate monohydrate). Nasonex is now indicated for the treatment of nasal congestion associated with seasonal allergic rhinitis in patients 2 years of age and older. Nasonex is also indicated for the treatment of nasal symptoms of allergic rhinitis, the prophylaxis of seasonal allergic rhinitis, and the treatment of nasal polyps.
Dosage Form:
Nasal spray: 50 mcg of mometasone furoate in each 100-microliter spray
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TarcevaMarketed by:
Roche (Nutley, NJ) and OSI Pharmaceuticals (Melville, NY)
Indication:
Roche and OSI Pharmaceuticals have gained FDA approval for a new indication for Tarceva (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy. Tarceva is already FDA approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least 1 course of chemotherapy. Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC. The dose for treatment of NSCLC is 150 mg/day.
Dosage Form:
Tablets: 25, 100, and 150 mg
For More Information:www.tarceva.com
877-TARCEVA (877-827-2382)
