Marketed by: Purdue Pharmaceutical Products LP (Stamford, CT)
Indication: The FDA approved Intermezzo (zolpidem tartrate) sublingual tablets, CIV for use as needed for the treatment of insomnia when middle of the night awakening is followed by difficulty returning to sleep. When a patient has fewer than 4 hours of bedtime remaining before the planned time of waking, however, Intermezzo is not indicated. Tablets should be placed under the tongue and allowed to disintegrate completely before swallowing and should not be swallowed whole. The effects of the drug may be slowed if taken with or immediately following a meal. The recommended dose is 1.75 mg for women and 3.5 mg for men. Intermezzo will be commercialized in the United States in the second quarter of 2012.
Dosage Form: Sublingual tablets: 1.75 and 3.5 mg
For More Information: www.intermezzorx.com
Marketed by: Regeneron Pharmaceuticals Inc (Tarrytown, NY)
Indication: Eylea (aflibercept) was approved by the FDA for the treatment of patients with neovascular (wet) agerelated macular degeneration. Aflibercept acts as a soluble decoy receptor that binds vascular endothelial growth factor (VEGF)-A and placental growth factor, inhibiting the binding and activation of these cognate VEGF receptors. It is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in Eylea. The recommended dosage is 2 mg administered by intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg administered by intravitreal injection once every 8 weeks.
Dosage Form: Single-use vial for intravitreal injection: 40 mg/ mL
For More Information: www.eylea.com
Marketed by: Galderma Laboratories, LP (Fort Worth, TX)
Indication: Galderma announced the FDA approval of the first pump dispenser for Epiduo (adapalene and benzoyl peroxide) Gel 0.1%/2.5%. Epiduo is a once-daily water-based gel indicated for the topical treatment of acne vulgaris in patients 12 years and older. Patients using Epiduo should apply a thin film to the affected areas of the face and/or trunk once daily after washing, avoiding the eyes, lips, and mucous membranes. When using Epiduo, patients should avoid the sun and sunlamps, and should wear sunscreen and protective clothing when this is not possible. The pump will be available in the first quarter of 2012.
Dosage Form: Gel: each gram contains 1 mg adapalene and 25 mg benzoyl peroxide
For More Information: www.epiduo.com
Marketed by: Bristol-Myers Squibb Co (Princeton, NJ) and Eli Lilly and Co (Indianapolis, IN)
Indication: The FDA approved Erbitux (cetuximab) for use with chemotherapy for the treatment of late-stage (metastatic) head and neck cancer. The drug was previously approved in 2004 for the treatment of epidermal growth factor receptor-positive late-stage colon cancer after patients stopped responding to chemotherapy. Before the administration of Erbitux, patients should be premedicated with an H1 antagonist. The initial dose of Erbitux is a 400 mg/m2 120-minute intravenous infusion, followed by weekly 60-minute 250 mg/m2 infusions. The product carries a boxed warning regarding the risk of serious and sometimes fatal infusion reactions and the risk of cardiopulmonary arrest and/or sudden death.
Dosage Form: Single-use vial for intravenous injection: 100 mg/50 mL and 200 mg/100 mL
For More Information: www.erbitux.com PT