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Generic Version of Razadyne Receives Tentative FDA Approval
A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (Galantamine Hydrobromide), 4mg, 8mg and 12mg Tablets on February 28, 2005, the first day that an ANDA containing a Paragraph IV certification could be submitted based on the expiration of the New Chemical Entity (NCE) exclusivity on the product. Barr received notification from the FDA of the application's acceptance for filing in April 2005. Following receipt of notice from FDA, Barr notified Janssen, the New Drug Application (NDA) holder, and Synaptech, the patent owner, of Barr's challenge to the patents protecting Razadyne.
In June 2005, Janssen and Synaptech filed suit against Barr Laboratories in the District Court of Delaware to formally initiate the patent challenge process under the Hatch-Waxman Act. Trial is set for May 21, 2007. The 30- month stay for the case expires in August 2008.
Razadyne is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The product had annual sales of approximately $140 million for the twelve months ending March 2007, according to IMS sales data.
Source: Barr Pharmaceuticals