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Our Bureau

Plans to start production immediately

Hyderabad , April 13

Dr Reddy's Laboratories Ltd has announced that the US Food and Drug Administration has granted final approval for the company's abbreviated new drug application (ANDA) for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg.

In a press release here on Thursday, the company said it would commence commercial marketing of this product immediately.

Dr Reddy's had filed the ANDA for fexofenadine hydrochloride tablets with a Para-IV certification on all orange book patents in September 2002. The company was granted summary judgment with respect to three patents.

Five patents remain under litigation, which is pending at the United States District Court for the District of New Jersey. No date is currently set for trial, the company said.

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

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Dr. Reddy's Laboratories Ltd

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