Lupin gets USFDA nod for generic pain relieving drug

NEW DELHI, Nov 17:  Drug major Lupin today said its US arm Gavis has received approval from the US health regulator to market Hydrocodone Bitartrate and Acetaminophen tablets, a pain relieving drug, in the American market.
Gavis Pharmaceuticals, a subsidiary of the company, has has received final approval for its Hydrocodone Bitartrate and Acetaminophen tablets from the US Food and Drug Administration (USFDA), Lupin said in a statement.
The company’s product, which is indicated for relief from moderate to moderately severe pain, is a generic equivalent of Mikart Inc’s Hydrocodone Bitartrate and Acetaminophen tablets.
As per IMS MAT sales data, Hydrocodone Bitartrate and Acetaminophen tablets had sales of USD 89.6 million in the US market.
Currently, Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA.
Cumulative filings of the company with the USFDA now stand at 339, with the company having received approvals for 198 products.


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