Lupin receives US approval for another drug
July 31st, 2008 - 5:07 pm ICT by IANS
New Delhi, July 31 (IANS) Drug major Lupin Ltd announced Thursday that its US subsidiary, Lupin Pharmaceuticals Inc (LPI) has received final approval for the company’s Abbreviated New Drug Application (ANDA) for divalproex sodium delayed-release tablets from the US Food and Drug Administration (FDA). The tablets will be available in 125 mg, 250 mg and 500 mg variants. Commercial shipments have commenced, the company said in a regulatory statement Thursday.
With the approval of this tablet the cumulative ANDA approvals of the company stand at 31 with 34 pending approval from the FDA.
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Tags: abbreviated new drug application, commercial shipments, divalproex sodium, fda, final approval, food and drug, food and drug administration, food and drug administration fda, lpi, New Delhi, pharmaceuticals inc, release tablets, subsidiary, us food and drug administration
