French drug delivery firm Flamel Technologies (Nasdaq: FLML) announced yesterday (June 5) that the US Food and Drug Administration has approved its New Drug Application for Bloxiverz (neostigmine methylsulfate), which came with last year’s acquisition of US specialty pharma company Eclat Pharmaceuticals (The Pharma Letter March 19, 2012).
The drug is used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz in the USA in July 2013 in 0.5 and 1.0mg/mL strengths.
"We are extremely excited and pleased to receive this FDA approval for Bloxiverz, the first product from the portfolio of Éclat products acquired in March 2012," said Mike Anderson, chief executive of Flamel.
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