FDA revises iPLEDGE dates
Executive Summary
FDA revises implementation dates for iPLEDGE, the risk management program for Roche's Accutane and isotretinoin generics, to allow more time for registration and activation, agency announces Oct. 28. Wholesalers and pharmacies must now be registered/activated on iPLEDGE by Dec. 30, rather than Nov. 1. The patient registration start date also has been pushed back from Nov. 1 to Dec. 30. After March 1, only prescribers activated in iPLEDGE are permitted to prescribe isotretinoin to patients who are registered in the risk management program. FDA adopted the program in August as part of a restricted distribution initiative aimed at preventing pregnancies in patients taking the acne medication (1"The Pink Sheet" Aug. 22, 2005, p. 12)...
You may also be interested in...
Accutane Update Is First Time For Wholesaler Instructions In A Product Label
A recently approved risk management program to prevent pregnancies in patients taking isotretinoin (Roche's Accutane and generics) includes the unprecedented addition of wholesaler-focused instructions to prescription drug labeling
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.