|
|
Article: Barr Receives Approval for Generic Version of Razadyne(R) Tablets.
- Article from:
- PR Newswire
- Article date:
- August 28, 2008
CopyrightCOPYRIGHT 2008 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
MONTVALE, N.J., Aug. 28 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne(R) (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005, the first day that an ANDA containing a ...