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  5. Cipher Pharmaceuticals Inc. - 11/30/2017
  1. Warning Letters


Cipher Pharmaceuticals Inc.


Recipient Name
Robert D. Tessarolo
Recipient Title
President and Chief Executive Officer
Cipher Pharmaceuticals Inc.

440 Monticello Avenue, Suite 2200
Norfolk, VA 23510
United States

Issuing Office:
The Office of Prescription Drug Promotion (OPDP)

United States

RE: NDA 22370
CONZIP® (tramadol hydrochloride) extended-release capsules for oral use, CIV
MA 12

Dear Mr. Tessarolo:

This letter responds to Cipher Pharmaceuticals Inc.’s (Cipher) September 8, October 5, and November 23, 2017, correspondence(s) submitted to the Office of Prescription Drug Promotion (OPDP) in response to OPDP’s August 24, 2017, Warning Letter regarding a violative professional detail aid for CONZIP (tramadol hydrochloride) extended-release capsules for oral use, CIV (ConZip). Reference is also made to the September 21, 2017 teleconference between OPDP and Cipher.

OPDP’s Warning Letter requested that Cipher immediately cease misbranding ConZip and/or cease introducing the misbranded drug into interstate commerce as discussed in the Warning Letter, submit a written response on or before September 8, 2017, stating whether you intended to comply with this request, list all promotional materials (with the 2253 submission date) for ConZip that contain statements such as those described in the Warning Letter, and explain Cipher’s plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of ConZip. We also requested that Cipher present a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the Warning Letter to the audience(s) that received the violative promotional materials.

OPDP acknowledges that Cipher has:

  •  Discontinued the dissemination of the violative professional detail aid and all other promotional materials with same or similar claims cited in the Warning Letter for Conzip.
  •  Submitted a corrective dear healthcare professional letter under cover of Form FDA-2253 on November 1, 2017.
  •  Submitted written confirmation to OPDP on November 23, 2017, that the dissemination of the aforementioned corrective messages was completed as described above.

In light of the actions that Cipher has taken, OPDP considers this matter closed. We remind you of your continuing obligation to ensure that all of your promotional materials comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, Division of Professional Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA 12 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.

{See appended electronic signature page}
Koung Lee, RPh, MSHS
Regulatory Review Officer
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion

This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic

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