FDA WARNING_LETTER - Ovation Pharmaceuticals, Inc.

The FDA's Center for Biologics Evaluation and Research issued a Warning Letter to Ovation Pharmaceuticals, Inc. regarding misleading promotional materials (Leave Behind Porphyria Letters for Healthcare Providers PHT094b & PHT094c) for PANHEMATIN (hemin for injection). The materials were found to be misleading due to failure to reveal material facts regarding serious risks and presentation of misleading efficacy claims, thus misbranding Panhematin in violation of 21 U.S.C. 352(a), 321(n), and 21 CFR 202.1(e)(3)(i), 202.1(e)(6)(i).

Specifically, the promotional materials omitted critical risk information, including contraindications (hypersensitivity) and adverse reactions (reversible renal shutdown with excessive doses), despite the approved product labeling containing a black box warning and detailed risk information. The inclusion of the full Prescribing Information (PI) with the promotional material was deemed insufficient to rectify this omission.

Furthermore, the materials presented misleading efficacy claims, such as "100% positive chemical response," implying clinical significance not supported by substantial evidence or clinical experience. The cited references were individual case studies, inconsistent with the approved indication (recurrent acute intermittent porphyria in susceptible women related to menstrual cycle), and even reported deaths. The claim that Panhematin "Is the only FDA-approved therapy for the treatment