Enforcement Report - Week of June 21, 2023
Enforcement Report - Week of November 30, 2022
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Lupin`s Generic Phenytoin Sodium Receives Approval in US
The European Medicines Agency (EMA) has hit pause on plans to improve product information after assessing the capacity constraints imposed by Brexit. EMA had hoped to spend the next two years implementing the plan, but will now hold off on starting most of the work until at least 2020.
It says its phenytoin sodium capsules are already cheaper than alternative drugs available in the UK and have been sold at a price negotiated with the Department of Health for the past nine years.
The Competition and Markets Authority said Pfizer and drug-distribution company Flynn Pharma Ltd. broke competition law by charging unfair prices in the U.K. for the drug, phenytoin sodium, used by about 48,000 patients in the country.
A top Pfizer ($PFE) executive joined the board of a National Health Service Trust in England, triggering questions about potential conflicts of interest, an NHS-focused news service reported on Wednesday.