BackSun Pharma gets US FDA go-ahead for four generic drugs
Sun Pharma gets US FDA go-ahead for four generic drugs
New Delhi: Drug major Sun Pharmaceutical Industries on Wednesday said the company, along with its subsidiary, has received abbreviated new drug application (ANDA) approval for four generic products from the US health regulator.
The company has received approvals from the US Food and Drug Administrator (FDA) for generic hydrocodone bitarlate with acetaminophen (APAP) tablets, generic Aredia Pamidronate Disodium injections, generic Lopid gemfibrozil tablets and generic Phenargan promethazine hydrochloride tablets in various strengths, Sun Pharma said in a statement.
These products — both generic and branded verions — all together have annualised sales of more than $650 million in the US.
The company has received the approval for 10 generic versions of Hydrocodone with APAP used as pain reliever for acute, chronic and post operative pains, it added.
While Lopid tablets are used as cholesterol reducing agents and generic Aredia injections can treat hypercalcemia, Phenargan tablets are pain relievers, the company said.
All these products are manufactured at multiple facilities of the company and its subsidiaries in the US and India.
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