Andrx naproxen ER approved
Executive Summary
Andrx' 500 mg naproxen extended-release ANDA clears FDA Aug. 27. SkyePharma waived its 180-day exclusivity for generic Naprelan after Andrx brought suit against SkyePharma and Elan, claiming they had entered a non-public anticompetitive settlement related to the product (1"The Pink Sheet" April 9, 2001, p. 4). Andrx expects to launch the generic in September. Company also has 375 mg strength tentatively approved at FDA...
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