Dr Reddy's new drug gets US FDA nod

Dr Reddy's Laboratories has announced that the US Food and Drug Administration (USFDA) has granted final approval for the company's abbreviated new drug application (ANDA) for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg. The company will commence the commercial marketing of this product immediately.

Fexofenadine hydrochloride is the AB-rated generic equivalent of Sanofi-Aventis' Allegra. The drug is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six years and above.

As per IMS, a global source for pharmaceutical market intelligence, the product has annual US brand sales of approximately $1.4 billion.

In September 2002, Dr Reddy's filed the ANDA for fexofenadine hydrochloride tablets with a Para IV certification on all orange book patents. Para IV filings permit challenges of existing patents and are typically followed by litigation with the innovator. Orange Book is the FDA's official register of approved pharmaceutical products.

The company was granted summary judgment with respect to three patents. Five patents remain in the litigation. The litigation is pending at the United States District Court for the district of New Jersey. No date has been currently set for trial, the company stated in a press release here on Thursday.

According to Dr Reddy's, the 30-month period identified in section 505(j)(5)(B)(iii) of the Federal Food, Drug and Cosmetic Act has expired. The 180-day generic drug exclusivity awarded to Barr Laboratories too has expired.