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. Multaq REMS released (February 12, 2016).
2. Xeljanz REMS released (February 8, 2016).
3. Isotretinoin iPLEDGE shared system REMS modified (February 4, 2016) to increase awareness and compliance with the appropriate classification of female patients of reproductive potential on the iPLEDGE Website by adding a Notice to Deter Patient Misclassification on select Prescriber and Designee screens. Also, removed Sponsor addresses from the Pregnancy Registry Protocol title page in the appended materials.
4. Saxenda REMS modified (February 1, 2016) to modify the REMS document for consistency with the presentation of current consumer/product websites.
5. Lotronex REMS and alosetron REMS modified (January 7, 2016) to modify the REMS Goal, remove the Medication Guide as an element of the REMS, and modifications to the elements to assure safe use including:
• The training of healthcare providers who prescribe Lotronex/alosetron hydrochloride must continue to be provided to ensure the benefits of Lotronex/alosetron hydrochloride continue to outweigh the risks of ischemic colitis and serious complications of constipation.
• The prescriber training materials are to include the Prescriber Education Slide Deck and a Safety Information Fact Sheet for Prescribers to communicate the key risk messages associated with Lotronex/alosetron hydrochloride.
• Prescribers no longer need to affix prescribing program stickers to written prescriptions for Lotronex/alosetron hydrochloride.
• Pharmacies may dispense Lotronex/alosetron hydrochloride without a prescribing program sticker affixed to a paper prescription.
• The Patient Acknowledgement Form was modified to a Patient Education Sheet and will become the primary educational tool used by prescribers for counseling patients regarding the risks of Lotronex/alosetron hydrochloride.
6. Transmucosal Immediate-Release Fentanyl (TIRF) shared system REMS modified (December 21, 2015) to revise the Medication Guide to include the new strength of 300mcg per spray.
7. Vivitrol REMS modified (December, 8 2015) to change the REMS appended materials including the "Key Techniques to Reduce Injection Site Reactions" Poster, and the Dear Healthcare Provider Letter.
New California Requirement for Some Cosmetics
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