Approved Risk Evaluation and Mitigation Strategies (REMS)

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Mycophenolate
Shared System REMS
REMS last update: 11/13/2015

What are Mycophenolate products?

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The Mycophenolate REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Cellcept (mycophenolate mofetil capsules) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 50722 Genentech 09/25/2012
Cellcept (mycophenolate mofetil injection) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 50758 Genentech 09/25/2012
Cellcept (mycophenolate mofetil oral suspension) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 50759 Genentech 09/25/2012
Cellcept (mycophenolate mofetil tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 50723 Genentech 09/25/2012
Myfortic (mycophenolate acid delayed-release tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 50791 Novartis Pharmaceuticals Corporation 09/25/2012
mycophenolate acid delayed-release tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 91558 Apotex Inc 09/25/2012
mycophenolate mofetil ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090661 Cadista Pharmaceuticals 12/15/2014
mycophenolate mofetil ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090762 Cadista Pharmaceuticals 12/15/2014
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 202720 Teva Pharmaceuticals USA 10/30/2014
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 203005 Alkem Laboratories, Ltd. 11/14/2014
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200197 Alkem Laboratories, Ltd. 09/27/2013
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65491 Teva Pharmaceuticals USA Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65410 Roxane Laboratories, Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65379 Sandoz, Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90419 Apotex Corporation 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90055 Strides Arcolab, Ltd. 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90111 Vintage Pharmaceuticals,LLC 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90253 Accord Healthcare Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65520 Mylan Pharmaceuticals Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65521 Mylan Pharmaceuticals Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 91249 Alkem Laboratories, Ltd. 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65416 Accord Healthcare Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90606 Vintage Pharmaceuticals,LLC 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90456 Strides Arcolab, Ltd. 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 90499 Apotex Corporation 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65413 Roxane Laboratories, Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65451 Sandoz Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 65457 Teva Pharmaceuticals USA Inc 09/25/2012
mycophenolic acid delayed-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091248 Mylan Pharmaceuticals 01/08/2014

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe mycophenolate-containing products

  • Receive training provided by the sponsor.
  • Review the educational materials for prescribers, including: Mycophenolate Program Brochure for Healthcare Providers.
  • Report the completion of training to the sponsor using the Prescriber Training Confirmation Form.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


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Material Name
Brochure for Healthcare Providers (PDF)
Center Training Confirmation Form (PDF)
DHCP Introductory Letter (PDF)
DHCP Letter for Centers (PDF)
Obstetrician/Gynecologist Referral Template Letter for Contraception Counseling (PDF)
Obstetrician/Gynecologist Referral Template Letter for Preconception Counseling (PDF)
Patient Brochure: What You Need to Know About Mycophenolate (PDF)
Patient-Prescriber Acknowledgement Form (PDF)
Prescriber Training Confirmation Form (PDF)
REMS Document (PDF)
REMS Full (PDF)
REMS Program Website Screenshots (PDF)

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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