Forest Laboratories Inc. Says FDA Did Not Approve Its Drug to Treat Mild Alzheimer's
Posted on: Friday, 29 July 2005, 21:00 CDT
Forest Laboratories Inc. said that the U.S. Food and Drug Administration has rejected its request to approve the drug Namenda to treat mild Alzheimer's disease.
The FDA issued a non-approvable letter in response to Forest's supplemental new drug application for Namenda, or memantine HCI.
Forest said it plans to meet with the FDA to further discuss the non-approvable letter.
Namenda was approved by the FDA for the treatment of moderate to severe Alzheimer's disease in October 2003.
Source: Long Island Business News
Related Articles
- GAO to Enquire into FDA's Drug Approval Policies
- Sagient Research Reports Significant Decline in FDA Drug Approval Rate
- Report Faults FDA Drug Safety Practices
- IOM: Wide Gaps in FDA Drug-Safety Process
- Senators plan bill to revamp FDA drug safety
- PROFNET WIRE: HEALTH & MEDICINE: FDA Drug Approval
- Think Your Drugs Are Manufactured in America? Think Again! FDA, Drug Companies Deceive Americans About Where Their Prescription Drugs Come From
- US advisers criticize FDA drug safety board
- Sepracor's Arformoterol NDA Filed By FDA; Drug Candidate for Chronic Obstructive Pulmonary Disease Moves Into Formal Review
- Neurobiological Technologies, Inc. Reports FDA Has Accepted Forest Lab's sNDA Filing to Expand Namenda's Indication to Include Mild Alzheimer's Disease
User Comments (0)


RSS Feeds