FDA gives nod to first once-daily protease inhibitor
July 21st 2003A protease inhibitor (PI) that circumvents the problems of earlier PIs such as certain adverse events, a complex dosing regimen, and toxicities such as lipid disturbances and glucose metabolism will soon be available to those infected with HIV. The FDA recently approved atazanavir (Reyataz, Bristol-Myers Squibb) for use in combination with other antiretroviral agents for the treatment of HIV infection. Atazanavir will be available in pharmacies sometime this month.
New flu vaccine caters to the "needle-phobic"
July 21st 2003Just in time for the 2003/2004 flu season, clinicians will be able to offer their "needle phobic" patients the first cold-adaptive, live-attenuated influenza vaccine (CAIV) that is administered as a nasal spray. The FDA recently approved influenza virus vaccine live, intranasal (FluMist, MedImmune Vaccines/Wyeth Vaccines) for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years old, and healthy adults, 18 to 49 years old. The vaccine will be available in pharmacies beginning in the late summer to early fall.
New drug could increase "on" time in Parkinson&s patients
July 7th 2003Clinicians who treat persons with Parkinson&s disease will soon be able to offer them the first drug to be approved for the treatment of Parkinson&s in 3 years. The FDA recently approved carbidopa, levodopa, and entacapone (Stalevo, Novartis/Orion Pharma) for the treatment of persons with idiopathic Parkinson&s disease. This new product is indicated as a substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual drugs, and as a replacement for immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience end-of-dose "wearing-off." Stalevo will be available during the third quarter of 2003.
Second biologic launched for those with A1PI deficiency
July 7th 2003Patients with a hereditary form of emphysema caused by alpha-1 proteinase inhibitor (A1PI) deficiency now have another therapeutic option. The FDA recently approved alpha1-proteinase inhibitor (human) [Aralast, Baxter] for chronic augmentation therapy in patients having congenital deficiency of A1PI with clinically evident emphysema. Aralast is currently available exclusively through the specialty pharmacy providers Accredo Health, Caremark, and Coram Healthcare. To obtain more information about Aralast, contact Baxter at (800) 423-2090.
New drug could increase "on" time in Parkinson&s patients
July 7th 2003Clinicians who treat persons with Parkinson&s disease will soon be able to offer them the first drug to be approved for the treatment of Parkinson&s in 3 years. The FDA recently approved carbidopa, levodopa, and entacapone (Stalevo, Novartis/Orion Pharma) for the treatment of persons with idiopathic Parkinson&s disease. This new product is indicated as a substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual drugs, and as a replacement for immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience end-of-dose "wearing-off." Stalevo will be available during the third quarter of 2003.
Is Medicare's new functional equivalence standard fair?
June 16th 2003CMS' ruling that Aranesp and Procrit are functionally equivalent so they should get the same reimbursement is creating a stir among drug companies which feel that one product has more advantages than the other and should deserve more payment.