Bayer HealthCare Pharmaceuticals announced that a reformulation of the liquid Leukine (sargramostim) has been approved by FDA and is now available for patients and physicians in the US. The new formulation does not contain EDTA (edetate disodium), which was in the product’s liquid 500 mcg vial manufactured from January 2006 to January 2008.
Tibotec Therapeutics announced the availability of a new 600 mg tablet strength for Prezista (darunavir), a protease inhibitor (PI). The new dosage strength was approved by the FDA in February. The recommended oral dose of PREZISTA for treatment-experienced adult patients with HIV-1 is 600 mg (one 600 mg tablet or two 300 mg tablets) taken twice daily with ritonavir 100 mg, in combination with other antiretroviral agents, and with food. The 300 mg tablet will remain available as long as there is sufficient demand for it.
