Sun Pharma gets USFDA approval for 4 generic drugs

Posted on: January 7, 2009 at 9:56 pm | 18 views




Drug maker Sun Pharmaceutical Industries announced that the company along with its subsidiaries had received final approval from US Food and Drug Administration (USFDA) forĀ  several abbreviated new drug applications (ANDA).

Approval was received for generic hydocodone bitarlate with acetaminophen (APAP) tablets. Approval was also received for generic `Aredia`, paamidronate disodium for injection USP, generic Lopid, gemfibrozil tablets, USP and promethazine hydrochloride tablets.

The approvals for the hydocodone with APAP are the first approvals for products based on controlled substances, the company disclosed. Hydocodone with APAP is a narcotic analgesic indicated in the treatment of relief of moderate to moderately severe pain of acute, chronic or post-operative types.

-IRIS.

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