Aurobindo receives approval for generic Razadyne, Monopril

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

On Thursday, the FDA approved Aurobindo’s fosinopril sodium tablets in the 10-, 20- and 40-mg strengths. The drug is a generic version of Bristol-Myers Squibb’s Monopril and is used to treat hypertension. Versions of the drug had sales of $20 million during the 12-month period ended in September 2010, according to IMS.

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