FYI - MORE DELAY - ANYU COMMENTS???
Myotrophin NDA Review Period Extended
WEST CHESTER, Pa., and EMERYVILLE, Calif., Aug. 11 /PRNewswire/ -- Cephalon, Inc.
(Nasdaq:CEPH) and Chiron Corp. (Nasdaq:CHIR) announced today that they have been informed
that the U.S. Food and Drug Administration (FDA) has extended until November 11, 1997, the
review period for the new drug application (NDA) submitted for clearance to market
MYOTROPHIN(R) Injection (mecasermin) in the United States for the treatment of amyotrophic
lateral sclerosis (ALS, or Lou Gehrig's disease). Cephalon and Chiron submitted the NDA on
February 11, 1997, and recently submitted an amendment to the NDA, which entitles the FDA to
extend its review deadline by three months.
Chiron Corporation, headquartered in Emeryville, CA, is a science-driven, market-directed
healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling
disease. Chiron participates in four global healthcare markets: diagnostics, including
immunodiagnostics, critical care diagnostics and new quantitative probe tests; therapeutics, with an
emphasis on oncological, infectious, neurological and cardiovascular disease; pediatric and adult
vaccines; and ophthalmic surgical products for the correction of vision. Chiron also conducts
research and development in the fields of biological proteins, gene therapy and combinatorial
chemistry.
Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical company
that discovers, develops and markets products to treat neurological disorders. The company is
developing products for the treatment of ALS, narcolepsy, peripheral neuropathies, Alzheimer's
disease and stroke, and currently co-promotes three products in the United States for the treatment
of neurological conditions.
This news release may contain forward-looking statements that involve risks and uncertainties. A full
discussion of the companies' operations and financial condition, including factors that may affect the
companies' business and future prospects, is contained in documents the companies file with the
SEC, such as form 10-Q and 10-K reports. These documents identify important factors that could
cause the companies' actual performance to differ from current expectations.
SOURCE: Cephalon, Inc.
More news for referenced ticker symbols: CEPH, CHIR, and related industries: medical.
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