Synvisc-One (hylan G-F 20)Genzyme Corp (Cambridge, MA) recently received FDA approval to market Synvisc-One. The product is
indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. Synvisc-One is the only single-injection viscosupplement approved for the treatment of OA knee pain in the United States. The product is an alternative treatment regimen to the company's Synvisc (hylan G-F 20), a 3-injection viscosupplement. Synvisc-One contains the same material and total treatment as Synvisc but provides the 6 mL of hylan G-F 20 in a single injection. Viscosupplementation is a procedure in which hyaluronic acid or a derivative such as hylan G-F 20 is injected into the knee joint to replace synovial fluid that typically becomes degraded in patients with OA. In synovial fluid, hyaluronic acid relieves pain and improves the knee joint's natural shocking abilities. For more information, visit www.synvisc.com, or call 888-379-6847.
Wyeth Pharmaceuticals (Collegeville, PA) recently received FDA approval for a new indication for Tygacil--
the treatment of adult patients with community-acquired bacterial pneumonia caused by susceptible strains of indicated pathogens. Tygacil also is approved for the treatment of complicated intra-abdominal infections and complicated skin and skin structure infections caused by susceptible strains of indicated pathogens in adults. The recommended dosage regimen for Tygacil is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of Tygacil should be administered over approximately 30 to 60 minutes every 12 hours. The recommended duration of treatment with Tygacil for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriologic progress. For more information, visit www.wyeth.com.
Copaxone (glatiramer acetate injection)Teva Pharmaceuticals (North Wales, PA) recently received FDA approval for an expanded indication for
Copaxone to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging features consistent with multiple sclerosis (MS). The product also is indicated for the reduction of the frequency of relapses in patients with relapsing/remitting MS. The recommended dose of Copaxone is 20 mg/day injected subcutaneously. The product is supplied as a single-use prefilled syringe containing 1.0 mL of a clear, colorless to slightly yellow, sterile, nonpyrogenic solution containing 20 mg of glatiramer acetate and 40 mg of mannitol, USP in cartons of 30 single-use prefilled syringes. For more information, visit www.copaxone.com.
(Cumberland, RI) to market Exactacain Topical Anesthetic Spray. The product provides rapid-onset (approximately 30 seconds), steady anesthesia with long-lasting effect (typically 30-60 minutes). Exactacain Topical Anesthetic Spray is used for the production of anesthesia of any accessible mucous membranes except the eye to control pain or gagging, and for use in surgical and endoscopic or other procedures of the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. The product is available in a 60-g can. For more information, visit www.eloquesthealthcare.com, or call 877-433-7626.