Horizon Pharma (Deerfield, IL)
The FDA approved Rayos (prednisone) delayed-release tablets as an anti-inflammatory or immunosuppressive agent for a variety of conditions, including certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, respiratory, renal, nervous system, rheumatologic, and specific infectious diseases or conditions, as well as organ transplantation. It is also approved for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions. Rayos should be taken with daily with food, and the tablets should not be broken, divided, or chewed.
Delayed-release tablets: 1, 2, and 5 mg
For More Information: www.rayosrx.com
Bayer HealthCare (Wayne, NJ) and Onyx Pharmaceuticals Inc (San Francisco, CA)
Stivarga (regorafenib) was approved by the FDA for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecanbased chemotherapy, an anti–vascular endothelial growth factor therapy and, when appropriate, an anti–epidermal growth factor receptor therapy. The recommended dose is 160 mg orally once daily for the first 21 days of each 28-day cycle. It should be taken with a low-fat breakfast. Stivarga carries a boxed warning against hepatotoxicity.
Film-coated tablets: 40 mg
For More Information: www.stivarga-us.com
sanofi-aventis US LLC (Bridgewater, NJ) and Regeneron Pharmaceuticals (Tarrytown, NY)
The FDA approved Zaltrap (zivaflibercept) injection for intravenous (IV) infusion in combination with 5-fluorouracil, leucovorin, and irinotecan for the treatment of metastatic colorectal cancer that is resistant or has progressed following an oxaliplatin-containing regimen. Zaltrap is administered as a 4-mg/kg IV infusion and never as an IV push or bolus. It carries a boxed warning against the risks of gastrointestinal perforation and compromised wound healing.
Single-use vials: 100 mg/4 mL and 200 mg/8 mL (both 25 mg/mL)
For More Information: www.zaltrap.com/hcp
Acton Pharmaceuticals (Marlborough, MA)
Acton Pharmaceuticals announced that the FDA approved its supplemental new drug application for Aerospan (flunisolide HFA, 80 mcg) inhalation aerosol. The product is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years and older. It is also indicated for patients with asthma who require oral corticosteroid therapy, where adding Aerospan may reduce or eliminate the need for oral corticosteroids.
Inhalation aerosol: 5.1 g net weight (60 metered acutations) and 8.9 g net weight (120 metered actuations)
For More Information: www.actonpharmaceuticals.com
Abbott (Abbott Park, IL)
Humira (adalimumab) was approved by the FDA for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to immunosuppressants. For UC, patients receive 160 mg initially, followed by a second dose of 80 mg in 2 weeks. Two days after the second dose, the maintenance dose of 40 mg every other week is initiated. Humira carries a boxed warning against the risk of serious infections and malignancy.
Single-use prefilled pen for injection: 40 mg/0.8 mL; single-use prefilled glass syringe for injection: 20 mg/0.4 mL and 40 mg/0.8 mL
For More Information: www.humira.com
Titanium Reusable Pellet Introducer Instrument
Afton Medical (Carson City, NV)
Afton Medical introduced a new titanium trocar for use with pellet forms of bioidentical hormone replacement therapy (BHRT). Available in 2 sizes, 4.5 mm for men and 3.0 mm for women, the titanium reusable pellet introducer instrument is ideal for the BHRT associated with the treatment of menopause, perimenopause, and andropause. BHRT pellets, which are placed under the skin, dissolve slowly over time, releasing a consistent amount of hormone each day.
Titanium trocar: 4.5 mm (male) and 3.0 mm (female)
For More Information
; 877-300- 6288