You are here

FDA Accepts Resubmitted NDA for Selegiline Antidepressant Patch

Pittsburgh, Pennsylvania/Corona, California - August 21, 2003 – Mylan Laboratories Inc. (NYSE: MYL) and Watson Pharmaceuticals, Inc. (NYSE: WPI) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Somerset Pharmaceutical, Inc.’s EMSAM™ selegiline transdermal therapy for which Somerset is seeking marketing clearance for the treatment of depression. Somerset is a joint venture between Mylan and Watson.

The amendment to the New Drug Application includes additional clinical data evaluating the safety and efficacy of EMSAM™ at 20mg, 30mg and 40mg doses as compared to placebo. In addition, results from a 1 year relapse study and supplemental safety studies were submitted. The FDA has provided an action date of February 1, 2004.

Source: Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc.

Recent Headlines

One in Five Kids’ Office Visits Results in an Off-Label Rx
Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds
Understanding Neural Ensembles in Infralimbic Cortex May Lead To Improved Addiction Treatment
Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids