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NexMed has completed enrollment for its Phase I study of NM100060, NexMed's
proprietary nail lacquer treatment for onychomycosis (nail fungal infection).
Kosan Biosciences has announced that its Phase II clinical trial of KOS-862
(Epothilone D) as monotherapy for patients with metastatic breast cancer will
proceed to full enrollment of the study following the successful completion
of the interim analysis.
BioSante Pharmaceuticals has completed its 12-week, pivotal Phase III clinical
trial to evaluate the safety and efficacy of Bio-E-Gel for the treatment of
moderate-to-severe hot flashes in menopausal women.
Alkermes has submitted a new drug application (NDA) to the FDA for marketing
approval of Vivitrex, an investigational drug in development for the treatment
of alcohol dependence.
Ivax has received FDA approval for cyclosporine oral solution USP in a 100-mg/mL
dose, and for cyclosporine capsules USP (modified) in 25-, 50- and 100-mg strengths.
The FDA has tentatively approved Mylan Pharmaceuticals' abbreviated new drug
application for olanzapine tablets in 2.5-, 5-, 7.5-, 10-, 15- and 20-mg strengths.
The FDA has approved GlaxoSmithKline's supplemental new drug application for
Zofran (ondansetron HCl) injection to prevent nausea and vomiting associated
with general anesthesia in children as young as 1 month and nausea and vomiting
associated with chemotherapy in children as young as 6 months.