In addition to the data from the original NDA and supplemental analyses of some of these data, the Adasuve resubmission contains new data from a successfully completed human factors study, stability data from new production batches manufactured in late 2010, updated manufacturing and controls sections addressing findings from the company's pre-approval Inspection, and updated draft labeling and a comprehensive risk evaluation and mitigation strategy
Also, Bristol-Myers Squibb has collaborated with the FDA to develop a Risk Evaluation and Mitigation Strategy
(REMS) to help ensure that the benefits of NULOJIX outweigh the risks of PTLD and PML, both of which can be fatal.
Pegloticase, which is administered intravenously every 2 weeks, is approved with a Risk Evaluation and Mitigation Strategy
(REMS), which will include materials for health care practitioners and a patient medication guide that explain the risks of severe infusion and allergic reactions associated with treatment, the FDA said in its statement.
At this time, however, mandatory registration of patients and prescribers in the risk management program is not included in the FDKs proposed risk evaluation and mitigation strategy
for long-acting (LA) and extended-release (ER) opioid drugs, an idea that had been considered a possibility and one that is included in the risk management programs for some other drugs.
Under a risk evaluation and mitigation strategy
(REMS), rosiglitazone will be available only to new patients with type 2 diabetes who are unable to adequately manage their blood glucose on pioglitazone or are unable to take pioglitazone, the only other approved thiazolidinedione.
The FDA has not yet completed the review of the New Drug Application (NDA) for ezogabine due to the recent submission of a formal REMS (Risk Evaluation and Mitigation Strategy
) for the drug.
In a written statement issued last month, the FDA announced that manufacturers of metoclopramide must add this warning to product labels, as well as implement a risk evaluation and mitigation strategy
(REMS) "to ensure patients are provided with a medication guide that discusses this risk." In the letter to manufacturers about the REMS requirement, the FDA refers to recently published analyses suggesting that metoclopramide "has surpassed haloperidol as the most common cause of drug-induced movement disorders."
According to the companies, the FDA has not yet completed the review of the New Drug Application (NDA) for ezogabine due to the recent submission of a formal REMS (Risk Evaluation and Mitigation Strategy
The FDA has required a risk evaluation and mitigation strategy
(REMS) for Bu-trans, which includes a medication guide that explains the risks of the drug and how to safely use it--the guide is provided to patients with each filled prescription.
The letter also specified that the proposed Risk Evaluation and Mitigation Strategy
(REMS) is not sufficient.
The FDA has also requested that Genentech, the manufacturer of efalizumab, submit plans for a risk evaluation and mitigation strategy
. Under legislation passed in 2007, the agency can require manufacturers to make safety labeling changes, and to plan a strategy for evaluating and managing a drug's risks, to ensure that the benefits of a drug outweigh its risks, when a safety issue is identified.