FDA Approves Four ANDAs for Sun Pharma

The FDA granted Sun Pharmaceutical Industries its first ANDA approval for a controlled substance, along with approvals for three additional generic drugs. The agency cleared the company’s hydro-codone bitartrate with acetaminophen (APAP) tablets and its generic formulations of Novartis’ Aredia (pamidronate disodium), Pfizer’s Lopid (gemfibrozil) and Wyeth’s Phenergan (promethazine HCl), India-based Sun says in a statement.
Washington Drug Letter