Mylan Wins FDA Approval for Generic Risperdal Tablets
Posted on: Wednesday, 17 September 2008, 12:00 CDT
Mylan Inc has announced that its subsidiary Mylan Pharmaceuticals Inc has received final approval from the FDA for its abbreviated new drug application for risperidone tablets USP, 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg.
Risperidone tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal tablets. Mylan will ship the product shortly.
Currently, the company has 109 abbreviated new drug applications pending FDA approval, 22 of which are potential first-to-file opportunities.
Source: Datamonitor
Related Articles
- Mylan Announces Final FDA Approval for Doxycycline Tablets
- Mylan Announces Final FDA Approval for Topiramate Tablets
- Mylan Announces Final FDA Approval for Cilostazol Tablets
- Mylan Announces Tentative Approval for Finasteride Tablets USP, 5mg
- Mylan Announces Tentative Approval for Fexofenadine Hydrochloride Tablets
- Mylan Announces Tentative Approval for Carvedilol Tablets
- Mylan Announces Tentative Approval for Rabeprazole Sodium Delayed-Release Tablets
- Mylan Announces Final Approval for Bisoprolol Fumarate Tablets, USP
- Mylan Announces Final FDA Approval for Glimepiride Tablets
- Mylan Receives Approval for Mercaptopurine Tablets USP, 50 Mg
Rating: 3.2 / 5 (9 votes)
 |
 |
Rate this article:
User Comments (0)
RSS Feeds