You are here
Tentative Approval Granted for Risperidone Tablets
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.
Liver Fluke Infestation Affects Almost 2.5 Million People Globally
Policy Could Be Life-Changing for People With Spinal Cord Injury
Test Determines Severity of Pain, Helps Physicians Select Best Options
Intratumoral Injection Stimulates Immune Activation
65,000+ New Diagnoses in U.S. Expected in 2019
Diabetes and Cancer Patients Could Soon Avoid Injections
Early Cancer Development May Begin in Just 30 Minutes
New Administration Option for Patients
New Treatment Option for Patients with aTTP