Hi-Tech (HITK) Gets FDA Approval for Generica Keppra ANDA
Hi-Tech Pharmacal Co., Inc. (Nasdaq: HITK), reports that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Levetiracetam oral solution 100mg/mL, the generic for UCB Pharma’s Keppra oral solution which had combined brand and generic sales of $62 million for the 12 months ended December 2011 according to IMS sales data. The product is used to treat partial onset seizures in people 16 years of age and older with epilepsy. Hi-Tech plans to launch the product by May 2012.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- ChemoCentryx (CCXI) Reports CCX168 Granted Ophan Drug Designation by U.S. FDA
- Novavax (NVAX) Receives FDA Fast-Track Designation for RSV F Vaccine Candidate
- UPDATE: KLA-Tencor (KLAC) Declares $16.50 Special Dividend; Yields 20.4%; Updates Q2 EPS Outlook
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!