Dr. Reddy's receives FDA approval for fexofenadine hydrochloride, generic of Allegra

By E. Janene Geiss

Philadelphia, April 13 - Dr. Reddy's Laboratories said Thursday that the Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg.

The company said it will begin marketing the product immediately, according to a company news release.

In September 2002, Dr. Reddy's said it filed the ANDA for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg with a Para IV certification on all orange book patents.

Dr. Reddy's was granted summary judgment with respect to three patents. Five patents remain in litigation pending at the U.S. District Court for the District of New Jersey. No date is currently set for trial.

The 30-month period identified in the Federal Food, Drug and Cosmetic Act has expired. The 180-day generic drug exclusivity awarded to Barr Laboratories also has expired, company officials said.

Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis' Allegra, which is indicated for the relief of seasonal allergies and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria. According to IMS in December 2005, the product had annual U.S. brand sales of about $1.4 billion.

Dr. Reddy's is a Hyderabad, India, pharmaceutical company.

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