Barr Receives Approval for Generic Version of Razadyne(R) E... ( MONTVALE N.J. Sept. 16 /- BarrPha...)Biology NewsMedicine NewsBiology ProductsMedicine ProductsBiology DefinitionMedicine DefinitionBiology TechnologyMedicine TechnologyBiology DictionaryMedicine Dictionary MONTVALE, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) 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) ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg. Barr also announced that it is the first company to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) containing a Paragraph IV certification for a generic version of Razadyne ER capsules, and therefore is entitled to 180-days of marketing exclusivity, as provided for under the Hatch Waxman Act. The Company intends to launch its product shortly.
