Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from U.S. FDA for several Abbreviated New Drug Applications (ANDA).
Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia(R), pamidronate disodium for injection USP, generic Lopid (R), gemfibrozil tablets, USP, and generic Phenargan(R), promethazine hydrochloride tablets.
First Controlled Substance approval
The approvals for Hydrocodone with 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. This is a Schedule III drug, regulated partly by the Controlled Substance Act of 1940 in the US.
Approvals have been received for ten generic versions of these tablets containing Hydrocodone and 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.
Hydrocodone + APAP Bioequivalent to strengths approved 5/500 mg Vicodin 5 /500 mg tablets of Abbott Laboratories 7.5/500 mg Hydrocodone with APAP 7.5 /500 mg tablets of Mikart Inc 10/500 mg Lortab 10/500 mg of UCB Pharma, Inc. 7.5/750 mg Vicodin ES tablets 7.5/ 750mg of Abbott Laboratories 7.5/650 mg Hydrocodone with APAP tablets 7.5/650 mg of Mikart Inc. 10/650 mg Hydrocodone with APAP 10 /650 mg tablets of Mikart Inc 10/660 mg Hydrocodone with APAP 10/660 mg of Mallinckdrodt, Inc 5/325 mg Norco tablets, Hydrocodone with APAP 5/325 mg, from Watson Laboratories 7.5/325 mg Norco tablets, Hydrocodone with APAP 7.5/ 325 mg, from Watson Laboratories 10/325 mg Norco tablets, Hydrocodone with APAP 10/325 mg, from Watson Laboratories
These strengths have annual sales of approximately USD 540 million in the US which includes branded as well as generic products.
Approval has also been received for generic Lopid(R) tablets. Generic Lopid contains gemfibrozil 600 mg, a cholesterol reducing agent and has annual sales of about USD 44 million in the US.
Approval for generic Aredia(R), pamidronate disodium for injection USP. Generic Aredia(R) 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. 30 mg/ vial and 90 mg/ vial. Genericand branded Aredia(R) has sales of approximately USD 20 million in the US.
In addition, approval was received for generic Phenargan tablets. promethazine hydrochloride USP. Generic Phenargan is an antihistamine/ antiemetic and is available as 12.5 mg, 25 mg and 50 mg tablets bioequivalent to generic Promethazine hydrochloride from Sandoz, Inc. Generic Phenargan(R) has sales of approximately USD 50 million in the US.
These products, to be manufactured at multiple facilities of Sun Pharma (together with its subsidiaries) in India and US, will reach market shortly.