Barr Laboratories Inc has received tentative approval from the US FDA for its generic version of Aventis Pharmaceuticals' Allegra-D (Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg) extended-release tablets. The Company anticipates receiving final approval and launching its generic product following the resolution of the patent challenge litigation surrounding this product, according to a Barr Pharmaceuticals release.

Allegra-D is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Allegra-D had annual sales of approximately $450 million, based on IMS data for the twelve months ended April 2004.

Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine Hydrochloride 60 mg and Pseudoephedrine Hydrochloride 120 mg extended-release tablets in September 2001, and received notification of the application's acceptance for filing in November 2001. Following receipt of notice from FDA, Barr notified Aventis of its ANDA filing. The Company believes it was the first applicant to file an ANDA containing a paragraph IV patent challenge on some of the patents relating to the Allegra-D product. Aventis filed suit in the United States District Court for the District of New Jersey seeking to prevent final approval of Barr's ANDA until after the expiration of various patents, the last of which expires in 2018, the release says.

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.