Saturday, January 10, 2009

Sun Pharma Receives USFDA Approvals - Jan 10, 2009

Sun Pharmaceutical Industries has announced that it has received final approval from USFDA for several Abbreviated New Drug Applications (ANDA). The approval was received for generic hydocodone bitarlate with acetaminophen (APAP) tablets in line with for generic Aredia, pamidronate disodium for injection USP, generic Lopid, gemfibrozil tablets, USP and generic phenargan, promethazine hydrochloride tablets.

The approvals for Hydrocodone with APAP are the first approvals for products based on controlled substances. However, the approvals have been received for ten generic versions of these tablets that containing Hydrocodone as well as APAP in the following strengths: 5/325 mg, 7.5/325 mg, 10/325 mg, 5/500 mg, 7.5/500 mg, 10/500 mg, 7.5/650 mg, 10/650 mg, 10/660 mg and 7.5/750 mg.

Apart from this, the approval has also been received for generic Lopid tablets. Generic Lopid contains gembrozil 600 mg, a cholesterol reducing agent. The approval for generic Aredia, pamidronate disodium for injection USP.

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