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Approved Risk Evaluation and Mitigation Strategies (REMS)

Mycophenolate
Shared System REMS
REMS last update: 08/13/2024

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Myhibbin (mycophenolate mofetil) (Info at Drugs@FDA) NDA 216482 AZURITY 05/01/2024
Cellcept (mycophenolate mofetil capsules) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050722 ROCHE PALO 09/25/2012 81ca6530-76d1-46f1-9bf8-0ffac79d2523 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050722
Cellcept (mycophenolate mofetil injection) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050758 ROCHE PALO 09/25/2012 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050758
Cellcept (mycophenolate mofetil oral suspension) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050759 ROCHE PALO 09/25/2012 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050759
Cellcept (mycophenolate mofetil tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050723 ROCHE PALO 09/25/2012 ca059bbf-0341-4e9d-8537-8b0c30ff42c7 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050723
Myfortic (mycophenolate acid delayed-release tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050791 NOVARTIS 09/25/2012 eed26501-890d-4ff6-88e7-6dbea4726e53 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050791
mycophenolate ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 217031 BIOCON PHARMA 07/31/2024 a5505ac0-69ee-44d1-99ce-00a496d9c797 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=217031
mycophenolate acid delayed-release (Info at Drugs@FDA) ANDA 214289 TWI PHARMS 11/03/2021
mycophenolate acid delayed-release tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091558 APOTEX INC 09/25/2012 c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091558
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 090661 JUBILANT CADISTA 12/15/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090661
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 090762 JUBILANT CADISTA 12/15/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090762
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 202720 TEVA PHARMS USA 10/30/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202720
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 203005 ALKEM LABS LTD 11/14/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203005
mycophenolate mofetil (Info at Drugs@FDA) ANDA 213955 HETERO LABS LTD V 11/13/2023
mycophenolate mofetil (Info at Drugs@FDA) ANDA 217828 AUROBINDO PHARMA LTD 01/05/2024
mycophenolate mofetil ( PI at DailyMed , Info at Drugs@FDA , Info at Drugs@FDA ) ANDA 210181 CONCORD BIOTECH LTD 01/09/2019 64ac00ee-298c-49cf-a91c-78019a0d014d
mycophenolate mofetil (Info at Drugs@FDA) ANDA 212087 CONCORD BIOTECH LTD 08/04/2020
mycophenolate mofetil (Info at Drugs@FDA) ANDA 212130 MEITHEAL 02/17/2021
mycophenolate mofetil (Info at Drugs@FDA) ANDA 214525 LANNETT CO INC 07/29/2021
mycophenolate mofetil capsules (Info at Drugs@FDA) ANDA 204077 ZHEJIANG HISUN PHARM 11/13/2017
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200197 ALKEM LABS LTD 09/27/2013 9f84ea84-2d8b-4d91-a33f-7dfb5df937dc http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200197
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065410 HIKMA 09/25/2012 e94895d9-f040-4a75-9f04-9814238b8f3c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065410
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065379 SANDOZ 09/25/2012 99b2eb58-8d14-48fc-bbe1-aacb711a783e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065379
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065491 TEVA PHARMS 09/25/2012 b414303f-e6f3-4e22-a537-96be352b59a4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065491
mycophenolate mofetil capsules ( Info at Drugs@FDA ) ANDA 090111 STRIDES PHARMA 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090111
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090055 STRIDES PHARMA 09/25/2012 209efe01-7908-46e4-a964-0665078c0acd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090055
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090253 ACCORD HLTHCARE 09/25/2012 741e079a-646b-47ec-84ac-8e12574c2aaf http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090253
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065520 MYLAN 09/25/2012 52907069-4a29-4351-a830-a9ee86b5ff7c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065520
mycophenolate mofetil for injection ( Info at Drugs@FDA ) ANDA 203575 ENDO OPERATIONS 10/28/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203575
mycophenolate mofetil for injection ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204043 RISING 02/28/2017 f186e133-1796-4689-9bf5-c074ba21ed30 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204043
mycophenolate mofetil for injection ( Info at Drugs@FDA ) ANDA 203859 MYLAN LABS LTD 03/31/2017 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203859
mycophenolate mofetil for injection (Info at Drugs@FDA) ANDA 204473 ZYDUS PHARMS 08/31/2017
mycophenolate mofetil for injection (Info at Drugs@FDA) ANDA 211374 AMNEAL 03/05/2021
mycophenolate mofetil for injection (Info at Drugs@FDA) ANDA 216390 STERISCIENCE SPECLTS 12/23/2022
mycophenolate mofetil for oral suspension (Info at Drugs@FDA) ANDA 212634 STRIDES PHARMA 08/29/2023
mycophenolate mofetil for oral suspension (Info at Drugs@FDA) ANDA 210370 VISTAPHARM 02/12/2019
mycophenolate mofetil oral suspension (Info at Drugs@FDA) ANDA 218227 AUROBINDO PHARMA LTD 09/26/2024
mycophenolate mofetil oral suspension (Info at Drugs@FDA) ANDA 214871 AMNEAL 11/02/2021
mycophenolate mofetil oral suspension (Info at Drugs@FDA) ANDA 211272 TEVA PHARMS USA 01/25/2022
mycophenolate mofetil tablets (Info at Drugs@FDA) ANDA 217937 AUROBINDO PHARMA 02/20/2024
mycophenolate mofetil tablets (Info at Drugs@FDA) ANDA 204076 ZHEJIANG HISUN PHARM 11/16/2017
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065521 MYLAN 09/25/2012 74c3a01e-9451-0f2f-6aab-8348047cb1f5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065521
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091249 ALKEM LABS LTD 09/25/2012 9f84ea84-2d8b-4d91-a33f-7dfb5df937dc http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091249
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065416 ACCORD HLTHCARE 09/25/2012 741e079a-646b-47ec-84ac-8e12574c2aaf http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065416
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090456 STRIDES PHARMA 09/25/2012 209efe01-7908-46e4-a964-0665078c0acd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090456
mycophenolate mofetil tablets ( Info at Drugs@FDA ) ANDA 090606 AMNEAL 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090606
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065457 TEVA PHARMS 09/25/2012 b414303f-e6f3-4e22-a537-96be352b59a4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065457
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065451 SANDOZ 09/25/2012 fa37d1be-c5a5-41c6-88ea-218f551dbbb5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065451
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065413 HIKMA 09/25/2012 e94895d9-f040-4a75-9f04-9814238b8f3c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065413
mycophenolic acid (Info at Drugs@FDA) ANDA 218603 AUROBINDO PHARMA LTD 02/27/2024
mycophenolic acid (Info at Drugs@FDA) ANDA 214630 BIOCON PHARMA 11/29/2021
mycophenolic acid (Info at Drugs@FDA) ANDA 211173 CONCORD BIOTECH LTD 12/13/2019
mycophenolic acid (Info at Drugs@FDA) ANDA 214376 AMTA 02/10/2021
mycophenolic acid delayed release tablets (Info at Drugs@FDA) ANDA 202555 ACCORD HLTHCARE 08/23/2017
mycophenolic acid delayed-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091248 RK PHARMA 01/08/2014 d7fbf301-0b08-4b19-bfa0-e0c0067cb5ab http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091248
mycophenolic acid delayed-release (Info at Drugs@FDA) ANDA 208315 ALKEM LABS LTD 09/23/2021

What is the purpose of the REMS?

The goal of the Mycophenolate REMS is to mitigate the risk of embryo-fetal toxicity associated with use of mycophenolate during pregnancy by:

  1. Educating healthcare providers on the following:
    • The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
    • The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
    • The need to report pregnancies to the Mycophenolate Pregnancy Registry.
  2. Informing females of reproductive potential who are prescribed mycophenolate about:
    • The increased risks of pregnancy loss (miscarriage) and birth defects.
    • The importance of pregnancy prevention and planning when taking mycophenolate.

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 that prescribe mycophenolate-containing products:

  • Receive training provided by the applicant or accredited CE provider
  • For training provided by applicants: review the educational material for prescribers: Healthcare Provider Brochure. | Healthcare Provider Brochure |
  • For training provided by accredited CE providers: complete the REMS-compliant training, including the knowledge assessment.
  • Report the completion of training to the applicant using the Prescriber Training Confirmation Form. | 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.

Material Name Material Name Link
Center Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Center_Training_Confirmation_Form.pdf
Dear Healthcare Provider Letter 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Dear_Healthcare_Provider_Letter_1.pdf
Dear Healthcare Provider Letter 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Dear_Healthcare_Provider_Letter_2.pdf
Dear Healthcare Provider Letter for Centers 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Dear_Healthcare_Provider_Letter_for_Centers_1.pdf
Dear Healthcare Provider Letter for Centers 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Dear_Healthcare_Provider_Letter_for_Centers_2.pdf
Healthcare Provider Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Healthcare_Provider_Brochure.pdf
Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf
Mycophenolate REMS Education Blueprint for Healthcare Providers Who Prescribe (FDA Blueprint) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_04_08_Mycophenolate_REMS_Education_Blueprint_for_Healthcare_Providers_Who_Prescribe_FDA Blueprint.pdf
Patient Information Brochure: What You Need to Know About Mycophenolate (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Patient_Information_Brochure__What_You_Need_to_Know_About_Mycophenolate.pdf
Prescriber Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Prescriber_Training_Confirmation_Form.pdf
Program Website (www.mycophenolaterems.com) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Program_Website_(www.mycophenolaterems.com).pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_REMS_Full.pdf
Website Banner (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2024_08_13_Website_Banner.pdf
Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
08/13/2024 Modified to:

1. Include Myhibbin (mycophenolate mofetil oral suspension) as an available mycophenolate prescription product in the Healthcare Provider Brochure, Patient Information Brochure: What You Need to Know About Mycophenolate, Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients, Prescriber Training Confirmation Form, Center Training Confirmation Form, and Program Website.

2. Update the REMS Document formatting to include the risk of embryo-fetal toxicity associated with the use of mycophenolate during pregnancy in the Administrative Information section.

04/08/2024 Revised to make editorial changes.
10/03/2023 Revised to update contact mailing information of the Mycophenolate REMS Coordinating Center
11/16/2021 Revised to reflect editorial changes.
08/11/2021 Modified to make changes to the Mycophenolate risk evaluation and mitigation strategy (REMS) website screenshots (non-CE and CE) to align the data insights section of the Patient Overview page with the data insights from the Patient Brochure.
04/21/2021 Modified to update the non-Continuing Education (CE) website screenshots to include a link on the homepage for the CE Request for Application (RFA).
01/15/2021

Modified to:

  1. Revise the patient-directed goal to make the language more patient-friendly and to align with the Medication Guide.
  2. Eliminate the Patient-Prescriber Acknowledgement Form to reduce burden on stakeholders
  3. Create two versions of the Center & Prescriber Training Confirmation Forms, Healthcare Provider Brochure, Center & Healthcare Provider Letters, & REMS website to address the availability of training prior to and after Continuing Education becomes available
  4. Include a list of professional medical societies and publishing schedule for the website banner
11/13/2015 Modified to:

  1. Address the knowledge and behavior gaps identified in the prescriber and patient surveys from the Year 2 REMS assessment, increase exposure of both healthcare providers and patients to the important safe use messages, and reinforce the importance of healthcare provider-patient dialogue in the modified and new REMS materials
  2. Modify the goals.
  3. Remove the Medication Guide as an element of the REMS.
09/27/2013 Modified to include information about the risk of reactivation of hepatitis B and hepatitis C virus in the Medication Guide, the shared Important Safety Information (ISI) included in the Dear Healthcare Provider (DHCP) Introductory Letter and DHCP Letter to Centers, and the Mycophenolate REMS website.
09/25/2012 Approval of the REMS.

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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