Marketed by: Merck & Co Inc (Whitehouse Station, NJ)
Indication: The FDA approved Juvisync (sitagliptin and simvastatin) tablets for patients in whom treatment with both sitagliptin and simvastatin is appropriate. Juvisync should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis. It has not been studied in patients with a history of pancreatitis or Fredrickson types I and V dyslipidemias. Patients with moderate or severe renal impairment who require sitagliptin 25 or 50 mg should not use Juvisync because these dosage strengths are not available. The recommended starting dose is 100 mg/40 mg (sitagliptin/simvastatin) once a day in the evening.
Dosage Form: Tablets (sitagliptin/simvastatin): 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg
For More Information: www.juvisync.com
Marketed by: Depomed Inc (Menlo Park, CA)
Indication: Depomed announced the FDA approval of Gralise (gabapentin) tablets for the management of postherpetic neuralgia, a painful condition that sometimes follows a case of shingles. Because of differing pharmacokinetic profiles that affect the frequency of administration, Gralise is not interchangeable with other gabapentin products. Patients should be titrated up to an 1800-mg dose that is taken once daily with their evening meal, and they should be advised to swallow the tablets whole and not chew, split, or crush them. A reduction in dose or the discontinuation of Gralise should be done gradually over a period of 1 week or longer.
Dosage Form: Tablets: 300 and 600 mg
For More Information: www.gralise.com
HIgH-Flo RMS Subcutaneous Needle Sets
Marketed by: RMS Medical Products (Chester, NY)
Indication: RMS Medical Products announced the availability of HIgH-Flo RMS Subcutaneous Needle Sets in the United States. These 26-gauge needles are available in single or multiple lead configurations and are designed to offer the flow rate of most sets that use larger 24-gauge needles, allowing patients more comfort during infusion. The HIgH-Flo Subcutaneous Needle Sets can be used with the Freedom60 infusion pump and flow rate tubing as a complete syringe infusion system for use in homes, infusion centers, and hospitals.
How Supplied: Subcutaneous needle: 26-gauge available in 6, 9, and 12 mm lengths
For More Information: www.rmsmedicalproducts.com; 800-624-9600
Marketed by: Genentech, a member of the Roche Group (South San Francisco, CA)
Indication: Genentech announced the availability of a new 6-mg/mL strength of Tamiflu (oseltamivir phosphate) for oral suspension. Tamiflu was previously approved by the FDA for the treatment of influenza in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older. The new strength does not foam as readily and includes a new oral dispenser with a milliliter scale to simplify dosing and administration. The 12-mg/mL strength of Tamiflu is no longer being manufactured.
Dosage Form: Powder for oral suspension: 360 mg oseltamivir base; capsules: 30, 45, and 75 mg
For More Information: www.tamiflu.com
Marketed by: Janssen Therapeutics, Division of Janssen Products, LP (Titusville, NJ)
Indication: Edurant (rilpivirine) is now FDA approved for use in combination with other antiretroviral agents in the treatment of HIV type 1 infection in treatment-naïve adult patients. Edurant is an HIV-1–specific nonnucleoside reverse transcriptase inhibitor that blocks the specific protein HIV-1 uses for replication. Coadministration of Edurant is contraindicated with drugs that may cause significant decreases in rilpivirine plasma concentrations, because this could result in loss of virologic response and possible resistance and cross-resistance. The recommended dose of Edurant is 25 mg taken once daily with a meal.
Dosage Form: Tablets: 25 mg
For More Information: www.edurant-info.com
Marketed by: Boehringer Ingelheim (Ridgefield, CT)
Indication: Boehringer Ingelheim announced the FDA approval of Combivent Respimat (ipratropium bromide and albuterol) for the treatment of patients with chronic obstructive pulmonary disease who use a regular aerosol bronchodilator and continue to have bronchospasm that necessitates a second bronchodilator. Combivent Respimat is a shortacting, propellant-free broncodilator that will be available to patients in the middle of 2012. The Combivent Respimat inhaler delivers 120 metered actuations, and the recommended dose is 1 inhalation 4 times a day, not to exceed 6 inhalations in a 24-hour period.
Dosage Form: Inhalation spray: 20 mcg ipratropium bromide and 100 mcg albuterol per actuation
For More Information: http://us.boehringer-ingelheim.com
Marketed by: Eli Lilly & Co (Indianapolis, IN)
Indication: The FDA approved Cialis (tadalafil) for once-daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and for the treatment of men with erectile dysfunction (ED) and the signs and symptoms of BPH. The product was previously approved for the treatment of ED. Cialis is a phosphodiesterase-5 inhibitor that can be taken without regard to food. For the new indications, the recommended dosage is 5 mg taken at approximately the same time every day. Patients taking any form of organic nitrate should not take Cialis, because it has been shown to increase nitrates’ hypotensive effects.
Dosage Form: Tablets: 2.5, 5, 10, and 20 mg
For More Information: www.cialis.com
Marketed by: Amylin Pharmaceuticals (San Diego, CA) and Eli Lilly & Co (Indianapolis, IN)
Indication: The FDA approved Byetta (exenatide) as an add-on therapy to insulin glargine with or without metformin and/or a thiazolidinedione in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. Byetta should not be used with short- or rapid-acting insulin and its concurrent use with prandial insulin has not been studied. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in patients with a history of pancreatitis.
Dosage Form: 250 mcg/mL exenatide in: 5 mcg/dose, 60-dose, 1.2-mL prefilled pen and 10 mcg/dose, 60-dose, 2.4-mL prefilled pen
For More Information: www.byetta.com PT