You are here
Tentative Approval Granted for Risperidone Tablets
April 5, 2004
PITTSBURGH--(BUSINESS WIRE)--April 5, 2004--Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Risperidone Tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Risperidone is the generic version of Janssen Pharmaceutica's Risperdal(R) Tablets.
Risperidone is one of ten potential first-to-file opportunities for Mylan currently before the FDA.
Source: Mylan Laboratories Inc.
U.S., Australia, and Canada Approve Endometrial Cancer Regimen
Single daily pill combines hypertension, cholesterol drugs
Drug With Androgen Deprivation Therapy Cut Risk of Death by 33% Compared With Placebo + ADT
A Diabetes Drug For People Without Diabetes
Roche Drug Outperformed Standard of Care in Phase 2 Study
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
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