Armenpharm, Ltd.; Suspension of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams; Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 50 Milligrams and 100 Milligrams, and Three Other Products Were Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA or Agency) is suspending approval of abbreviated new drug application (ANDA) 060851 for chloramphenicol capsules, 250 milligrams (mg), held by Armenpharm, Ltd. (Armenpharm), 49 South Ridge Rd., P.O. Box D1400, Pomona, NY 10970. FDA has also determined that CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 milliliters (mL), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL.