CLOSEOUT LETTER
Avanthi, Inc.
- Product:
- Drugs
- Recipient:
-
Recipient NameSameer Late, P.h.D.
-
Recipient TitleDirector, Regulatory Affairs
- Avanthi, Inc.
110 Terry Drive
Newtown, PA 18940
United States
- Issuing Office:
- The Office of Prescription Drug Promotion (OPDP)
United States
RE: ANDA 203495
LOMAIRA™ (phentermine hydrochloride USP) tablets, CIV
MA 47
Dear Dr. Late:
This letter responds to AVANTHI, Inc.’s (Avanthi) September 7, 2018, correspondence submitted to the Office of Prescription Drug Promotion (OPDP) in response to OPDP’s December 19, 2017, Warning Letter concerning a violative exhibit panel (panel) for LOMAIRA™ (phentermine hydrochloride USP) tablets, CIV (Lomaira). Further reference is made to Avanthi’s January 3, 2018, February 9, 2018, and May 22, 2018 correspondences to OPDP in response to the Warning Letter and to OPDP’s January 26, 2018, and May 30, 2018
letters.
OPDP’s Warning Letter requested that Avanthi immediately cease misbranding Lomaira and/or cease introducing the misbranded drug into interstate commerce as discussed in the Warning Letter, submit a written response on or before January 4, 2018, stating whether you intended to comply with this request, list all promotional materials (with the 2253 submission date) for Lomaira that contain statements such as those described in the Warning Letter, and explain Avanthi’s plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of Lomaira. We also requested that Avanthi 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 Avanthi has:
• Discontinued the dissemination of the violative panel and all other promotional materials with same or similar claims cited in the Warning Letter for Lomaira.
• Submitted a corrective Dear Health Care Provider Letter under cover of Form FDA-2253 on May 31, 2018.
• Submitted written confirmation to OPDP on September 7, 2018, that the dissemination of the aforementioned corrective message was completed as described above.
In light of the actions that Avanthi 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 47 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.
Sincerely,
{See appended electronic signature page}
Ankur Kalola
Regulatory Review Officer
Division of Advertising & Promotion Review 2
Office of Prescription Drug Promotion
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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
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/s/
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ANKUR S KALOLA
09/28/2018