Tuesday, March 24, 2015

FDA Medication Guide: Update

US Food and Drug Administration



The following are updated or newly added:
  • YERVOY (ipilimumab), Bristol-Myers Squibb Company
  • XARTEMIS XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, CII
  • VIIBRYD (vilazodone hydrochloride) Tablets, Actavis, Inc.
  • SIGNIFOR [sig-na-for] (pasireotide) Injection,
  • FARXIGA (dapagliflozin) tablets, Astra Zeneca Pharmaceuticals LP
  • DUETACT (pioglitazone and glimepiride) tablets, Takeda Pharmaceuticals America, Inc.
  • CIPRO (ciprofloxacin hydrochloride) Tablets for oral use, CIPRO® (ciprofloxacin hydrochloride) for oral suspension; CIPRO® XR (ciprofloxacin hydrochloride) Tablets, for oral use, CIPRO® IV (ciprofloxacin) Injection for intravenous infusion, Bayer HealthCare Pharmaceuticals Inc.
  • BONIVA (ibandronate), Genentech, Inc.
  • AVANDARYL (rosiglitazone maleate and glimepiride) tablets, GlaxoSmithKline

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

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