WASHINGTON, Feb 7 (Reuters) - A federal judge on
Tuesday upheld the Food and Drug Administration's approval of
the generic version of the blood thinner Lovenox sold by
Novartis AG's Sandoz and Momenta Pharmaceuticals.
The maker of Lovenox, Sanofi-Aventis, had sued the FDA in
2010, arguing that the agency had not followed its procedures
and did not ensure that the generic, known as enoxaparin, had
the same active ingredient as the name-brand version.
U.S. District Judge Amy Jackson sided with the FDA, finding
that the agency did not depart from its precedent in approving
the generic medicine and that the decision that the active
ingredient was the same was proper.
"Its approval of the drug did not constitute an arbitrary
departure from agency precedent, and its determination of active
ingredient sameness was not arbitrary and capricious, an abuse
of discretion, or otherwise not in accordance with the law," she
said in a 33-page ruling.
In August 2010, another judge refused to grant a temporary
restraining order against Sandoz and Momenta marketing the
generic drug.
Lovenox, which is a type of heparin and primarily used in
hospitals, had been one of Sanofi's top-selling drugs with
annual sales approaching $4 billion for the French drugmaker
before the generic began to be sold in the summer of 2010.
"Sanofi is disappointed that the court has ruled in favor of
the U.S. Food and Drug Administration regarding the abbreviated
new drug application (ANDA) for a generic enoxaparin," the
company said in a statement. "We are currently considering our
legal options."
Sanofi could appeal the ruling.
The case is Sanofi-Aventis v. Food and Drug Administration
et al, No. 10-cv-1255, in U.S. District Court for the District
of Columbia.
(Reporting by Jeremy Pelofsky)
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