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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993
TRANSMITTED BY FACSIMILE
ECR Pharmaceuticals, a wholly owned subsidiary of Valeant
Pharmaceuticals International
Attention: J. Michael Pearson, CEO Valeant Pharmaceuticals
International
400 Somerset Corporate Center
Bridgewater, NJ 08807
RE: ANDA 077273
TussiCaps
®
(hydrocodone polistirex and chlorpheniramine polistirex)
Extended-release Capsules CII
1
MA #86
WARNING LETTER
Dear Mr. Pearson:
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration
(FDA) has reviewed a professional sales aid (DTUS3B) (sales aid) for TussiCaps
®
(hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Capsules CII
(TussiCaps) submitted by ECR Pharmaceuticals under cover of Form FDA 2253. The sales
aid is false or misleading because it omits risk information, inadequately communicates the
full indication for the drug, and presents unsubstantiated claims for TussiCaps. Thus, the
sales aid misbrands TussiCaps within the meaning of the Federal Food, Drug and Cosmetic
Act (FD&C Act), and makes its distribution violative. 21 U.S.C. 352(a); 321(n); 331(a); 21
CFR 1.21(a). Cf. 21 CFR 202.1(e)(3)(ii); (e)(5); (e)(7)(i). These violations are concerning
from a public health perspective because they suggest that TussiCaps, a drug associated
with a number of serious and potentially fatal risks, is safer than has been demonstrated.
Background
Below are the indication and summary of the most serious and most common risks
associated with the use of TussiCaps.
2
1
The version of the TussiCaps PI that was approved when the piece cited in this letter was disseminated and
the version referred to in this letter is dated March 3, 2009. However, a new version of the PI was approved on
November 20, 2014.
2
This information is for background purposes only and does not necessarily represent the risk information that
should be included in the promotional piece cited in this letter.
Reference ID: 3801359