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Flamel Technologies (NASDAQ: FLML) has announced that it is the recipient of a Prescription Drug User Fee Act (PDUFA) date of April 30, 2016 from the FDA for its third New Drug Application filing.
Flamel Technologies (NASDAQ: FLML) has announced that it is the recipient of a Prescription Drug User Fee Act (PDUFA) date of April 30, 2016 from the FDA for its third New Drug Application filing.
According to the press release:
This is Flamel’s third filing to seek FDA approval of an Unapproved Marketed Drug (UMD), consistent with Flamel’s successful strategy in this portion of its product portfolio. Based on IMS and other third-party data, the Company estimates that current U.S. market sales of the unapproved versions of this drug are in the range of $70-$80 million per year. Flamel currently has two FDA-approved products on the market, including Bloxiverz® (neostigmine methylsulfate) and Vazculep® (phenylephrine hydrochloride).
Click here to read the full press release from Flamel Technologies.