viernes, 14 de agosto de 2015

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website updated

REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
  1. Extended-Release Long-Acting (ER/LA) opioid analgesics shared system REMS modified (on August 13, 2015) to change the ER/LA Opioid Analgesics REMS Blueprint to include the following information:
    • Incorporation of information regarding use of OXYCONTIN in the pediatric population
    • Addition of information to the titration recommendations for adult patients.
  2. Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) shared system REMS modified (on August 10, 2015) to update the language in the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Pharmacists brochure and the Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers brochure to permit the use of Zubsolv for the initial (“induction”) treatment of opioid dependence.
  3. Symlin REMS modified (on August 7, 2015) to change the REMS factsheet to the amend the listed adverse event phone number, due to the change in ownership of this NDA. Also, to change the REMS document to:
    • Modify the timeframes in which REMS letters will be sent to certain healthcare providers and professional societies;
    • Remove the requirement that the REMS letter be provided to Medwatch prior to the letter being issued;
    • Modify the timeframe in which the REMS Factsheet will be displayed at certain scientific meetings.
  4. Testosterone (ANDA 204571) REMS added (on August 05, 2015).
  5. Testosterone 1.62% (ANDA 204268) REMS added (on August 04, 2015).

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