New FDA Approvals
The FDA recently approved these drugs:
• The first generic version of Pfizer's Zoloft (sertraline) was approved in tablets and a liquid concentrate (sertraline HCl). Sertraline tablets are indicated for treating major depressive disorder in adults, while the liquid concentrate is approved for treating major depressive disorder and some anxiety-related disorders. Sertraline tablets are manufactured by Ivax Pharmaceuticals and the liquid concentrate by Roxane Laboratories.
• Prezista(darunavir), Ortho Biotech Products' new drug for adults whose HIV infection has not responded to treatment with other antiretroviral drugs was approved. Darunavir is a new HIV protease inhibitor that is approved to be coadministered with a low dose of ritonavir and other active anti-HIV agents. Ritonavir slows the breakdown of darunavir in the body, increasing its concentration in patients' systems.
FDA said its accelerated approval was based on evidence from two studies comparing the safety and effectiveness of a darunavir-ritonavir combination with other ritonavir-boosted protease inhibitor combinations. Some 70% of treatment-experienced patients achieved a virologic response, improving treatment outcome, with darunavir-ritonavir in combination therapy compared to 21% in the control group at week 24. Darunavir's risks and benefits have not been established for adults who have not been previously treated for HIV and for children.
The most common side effects reported by patients on the darunavir-ritonavir regimen included diarrhea, nausea, and headache. About 7% of patients on this combination therapy experienced skin rashes ranging from mild to serious.
As a condition of approval, Ortho Biotech is required to conduct post-marketing trials to verify and describe darunavir's clinical benefits. The company also will conduct studies to better define certain drug-drug interactions and to evaluate the drug in patients with varying degrees of liver impairment to identify appropriate dosing for this patient population.
The FDA recently approved these drugs: The first generic version of Pfizer's Zoloft (sertraline) was approved in tablets and a liquid concentrate (sertraline HCl).Subscribe Now for Access
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