SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.
The FDA has approved Horizant (gabapentin enacarbil), a drug made by GlaxoSmithKline and XenoPort, as a once-daily treatment for moderate-to-severe restless legs syndrome, the agency said.
The FDA announced the approval of AstraZeneca’s daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms, but who are ineligible for surgery, the agency said.
The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals’ single-pill antiretroviral for HIV-1 patients, BI said. Viramune XR (nevirapine) is a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.