The Mumbai-based Sun Pharmaceutical Industries Ltd has received Abbreviated New Drug Applications (ANDA) approval for four of its products from the US FDA.

According to the company, approval was received for generic versions of hydocodone bitartate with acetaminophen (APAP) tablets, Aredia, pamidronate disodium for injection USP, Lopid, gemfibrozil tablets, USP, and Phenargan, promethazine hydrochloride tablets.

The approvals for hydrocodone with APAP are the first of its kind 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. The company received approval for ten generic versions of the product containing hydrocodone and APAP in various strengths. These strengths have annual sales of approximately USD 540 million in the US which includes branded as well as generic products.

The generic Lopid tablets, a cholesterol reducing agent and has annual sales of about USD 44 million in the US even as the market of generic Aredia, pamidronate disodium for injection for the treatment of hypocalcaemia of malignancy, paget's disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma has a sales of approximately USD 20 million in the US.

In addition, generic Phenargan tablets, an antihistamine/ antiemetic have sales of approximately USD 50 million in the US. The products, would be manufactured at multiple facilities of Sun Pharma (together with its subsidiaries) in India and US, will reach market shortly.