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 050722 Roche Palo Alto LLC 09/25/2012
Cellcept (mycophenolate mofetil injection) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050758 Roche Palo Alto LLC 09/25/2012
Cellcept (mycophenolate mofetil oral suspension) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050759 Roche Palo Alto LLC 09/25/2012
Cellcept (mycophenolate mofetil tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050723 Roche Palo Alto LLC 09/25/2012
Myfortic (mycophenolate acid delayed-release tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050791 Novartis Pharmaceuticals Corporation 09/25/2012
mycophenolate acid delayed-release tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091558 Apotex Inc 09/25/2012
mycophenolate mofetil ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090661 Jubilant Cadista Pharmaceuticals, INC 12/15/2014
mycophenolate mofetil ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090762 Jubilant Cadista Pharmaceuticals, INC 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 090253 Accord Healthcare Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065520 Mylan Pharmaceuticals Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090419 Apotex Corporation 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090055 Strides Arcolab, Ltd. 09/25/2012
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 065410 Roxane Laboratories, Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065379 Sandoz, Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065491 Teva Pharmaceuticals USA Inc 09/25/2012
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090111 Vintage Pharmaceuticals,LLC 09/25/2012
mycophenolate mofetil for injection ( Info at Drugs@FDA ) ANDA 203575 Par Sterile products, LLC 10/28/2016
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090456 Strides Arcolab, Ltd. 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090499 Apotex Corporation 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065413 Roxane Laboratories, Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065521 Mylan Pharmaceuticals Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091249 Alkem Laboratories, Ltd. 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090606 Vintage Pharmaceuticals,LLC 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065457 Teva Pharmaceuticals USA Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065416 Accord Healthcare Inc 09/25/2012
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065451 Sandoz 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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