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 |
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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 207022 | HETERO LABS LTD V | 10/22/2024 | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process | |
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 216390 | STERISCIENCE SPECLTS | 12/23/2022 | ||
mycophenolate mofetil for injection (Info at Drugs@FDA) | ANDA 211374 | AMNEAL | 03/05/2021 | ||
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:
- 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.
- 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
Healthcare Providers that prescribe mycophenolate-containing products:
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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 |
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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:
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11/13/2015 | Modified to:
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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.