Novartis unit sues FDA over a Generic Drug for Human
Growth Hormone
13 September 2005
Sandoz, a division of Swiss drug manufacturing
giant Novartis stated that it sued the U.S. Food and
Drug Administration, seeking to force the agency to
make a decision on its application to sell a generic
human growth hormone.
Sandoz filed its application to sell the drug named
Omnitrope in July 2003 and has yet to receive a decision
from the FDA. The lawsuit, filed in U.S. District Court
for the District of Columbia, seeks to force the agency
to act on the Omnitrope application, the drug maker
said.
However, the situation is more complicated than ordinary
generic drug
approval decisions as new legislation is required to
give the FDA authority to approve copycat versions of
biotechnology medicines, which are far more complicated
to manufacture than common chemical drugs.
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