Marketed by: Schering Corp, a subsidiary of Merck & Co Inc (Whitehouse Station, NJ)
Indication: Victrelis (boceprevir) has been approved by the FDA for the treatment of chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin in patients 18 years or older with compensated liver disease, including cirrhosis, who have not received treatment or who have failed previous interferon and ribavirin therapy. Victrelis, a hepatitis C virus NS3/4A protease inhibitor, is not approved as a monotherapy and must be administered with peginterferon alfa and ribavirin. The dosage is 800 mg administered orally 3 times a day, or every 7 to 9 hours, with food. Safety and efficacy have not been studied in pediatric patients.
Dosage Form: Capsules: 200 mg
For More Information: www.victrelis.com
Rezira Oral Solution
Marketed by: Hawthorn Pharmaceuticals, a subsidiary of Cypress Pharmaceutical Inc (Madison, MS)
Indication: Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution (CIII) is a combination product approved by the FDA for the relief of cough and nasal congestion associated with the common cold. The dosage for adults 18 years and older is 5 mL every 4 to 6 hours as needed, not to exceed 4 doses, or 20 mL, in 24 hours. Rezira is not indicated for patients younger than 18 years. Rezira should be used with caution in patients with severe renal or hepatic impairment.
Dosage Form: Oral solution: 5 mL contains hydrocodone bitartrate 5 mg and pseudoephedrine hydrochloride USP 60 mg
For More Information: www.hawthornrx.com
Marketed by: Optimer Pharmaceuticals Inc (San Diego, CA)
Indication: The FDA approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile– associated diarrhea (CDAD) in patients 18 years and older. It is the first antibacterial drug indicated for the treatment of CDAD to be approved in almost 30 years. Dificid should not be used to treat systemic infections, and should be reserved for infections proved or strongly suspected to be caused by C difficile to reduce the development of drug-resistant bacteria. One 200-mg Dificid tablet should be taken orally twice daily for 10 days with or without food. Optimer plans to launch Dificid in the third quarter of 2011.
Dosage Form: Film-coated tablets: 200 mg
For More Information: www.dificid.com
Marketed by: Sanofi Pasteur Inc (Swiftwater, PA)
Indication: Sanofi Pasteur, the vaccines division of sanofiaventis Group, announced the FDA approval of their supplemental biologics license application for Fluzone Intradermal (Influenza Virus Vaccine). Fluzone Intradermal is indicated for active immunization against influenza disease caused by influenza subtypes A and B in patients aged 18 to 64 years. Patients who have had a severe allergic reaction to egg or a previous dose of influenza vaccine should not be immunized with Fluzone Intradermal. The previously approved vaccines Fluzone and Fluzone High-Dose are available as intramuscular injections. Dosage Form: Suspension for intradermal injection in a prefilled microinjection system: 0.1 mL
Marketed by: Centocor Ortho Biotech Inc (Horsham, PA)
Indication: Zytiga (abiraterone acetate) tablets were approved by the FDA after priority review for use in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer who have received prior chemotherapy containing docetaxel. Zytiga is a cytochrome P450 17 inhibitor and decreases the production of testosterone. The recommended dosage for Zytiga is 1000 mg orally once daily in combination with prednisone 5 mg orally twice daily. Zytiga must be taken on an empty stomach, and patients should not eat for at least 2 hours before or at least 1 hour after their dose. It is contraindicated in women who are pregnant or who may become pregnant.
Dosage Form: Tablets: 250 mg
For More Information: www.zytiga.com
Marketed by: Upsher-Smith Laboratories Inc (Maple Grove, MN)
Indication: Upsher-Smith Laboratories Inc announced the launch of Trianex 0.05% (triamcinolone acetonide ointment), a topical corticosteroid indicated for the relief of itching and inflammation caused by certain skin conditions that respond to treatment with corticosteroids, such as psoriasis and eczema. Trianex 0.05% has a preservative-free formulation with a proprietary hydrous emulsified base that feels like a cream, but provides ointment occlusivity to enhance absorption of the corticosteroid. Skin treated with Trianex 0.05% should not be bandaged, covered, or wrapped, unless directed by a physician.
Dosage Form: Ointment in 17- and 85-g tubes
For More Information: www.trianex-usl.com
Marketed by: Forest Pharmaceuticals, a subsidiary of Forest Laboratories (St Louis, MO)
Indication: The FDA approved Daliresp (roflumilast) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is not a bronchodilator, and is not indicated for the treatment of bronchospasm or intended to treat the form of COPD that involves primary emphysema. Daliresp is an inhibitor of phosphodiesterase type 4, and represents a new drug class for the treatment of COPD. For patients with COPD, the recommended dosage is one 500-mcg tablet per day, with or without food.
Dosage Form: Tablets: 500 mcg
For More Information: www.daliresp.com
Marketed by: Novo Nordisk (Princeton, NJ)
Indication: Novo Nordisk announced the launch of the NovoTwist needle, the first single-twist needle cleared for use in the United States. The NovoTwist needle is available for use with several NovoNordisk prefilled delivery devices, including Levemir (insulin detemir [rDNA origin] injection) FlexPen, NovoLog (insulin aspart [rDNA origin] injection) FlexPen, and Victoza (liraglutide [rDNA origin] injection) Pen. The design of the needle allows users to attach the needle to an injection pen in 1 twist, and has an audible and tactile click that confirms attachment. NovoTwist needles may require a prescription in some states, and are sold separately.
Dosage Form: Needles: 5 and 8 mm
For More Information: www.novonordisk.com