Dr. Reddy's Laboratories and Brisbane-based Alchemia Limited have announced that Dr. Reddy's received final approval for its ANDA for Fondaparinux Sodium injection, a bioequivalent generic version of Arixtra, by the U.S. Food and Drug Administration.

The approval would cover 2.5 mg/0.5 mL, 5 mr/0.4 mL, 7.5 mg/0.6mL and 10 mg/0.8 mL doses of the drug in prefilled colour-coded single dose syringes with automatic needle safety device.

DRL would manufacture Fondaparinux using a patented process developed by Alchemia, according to a release.

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