Fosun Pharma USA Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 075286 for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Fosun Pharma USA Inc. (Fosun), 104 Carnegie Center, Princeton, NJ 08540. Fosun requested that approval of this application be withdrawn and has waived its opportunity for a hearing.