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news.India-based Sun Pharmaceutical Industries has announced that together with its subsidiaries, it has received final approval from the FDA for several abbreviated new drug applications. Approval has also been received for four generic drugs.
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The approvals for Hydrocodone with acetaminophen (APAP) are the first approvals for products based on controlled substances. Hydrocodone 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.
Approvals have been received for 10 generic versions of these tablets containing Hydrocodone and APAP.
Approval has also been received for generic Lopid tablets and generic Aredia, pamidronate disodium for injection USP. Generic Lopid contains gemfibrozil 600mg, a cholesterol reducing agent.
Generic Aredia is indicated in the treatment of hypercalcemia of malignancy, paget’s disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. Approval has been received for two strengths, 30mg vial and 90mg vial.
In addition, approval was received for generic Phenargan tablets. Generic Phenargan is an antihistamine/antiemetic and is available as 12.5mg, 25mg and 50mg tablets bioequivalent to generic Promethazine hydrochloride from Sandoz.
These products, to be manufactured at multiple facilities of Sun Pharma (together with its subsidiaries) in India and the US, are expected to reach market shortly.