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      Dr Reddy's wants FDA to change rules


      The $1.6-billion Dr Reddy's Laboratories, shares of which are listed both in India and US stock markets, has knocked the doors of US Food and Drug Administration (FDA) to seek a change in rules which may allow the firm to get approval for its generic version of Fosamax Plus D, a drug used to treat and prevent Osteoporosis.

      The drug is sold by Merck & Co. and the patents on this drug will expire in December 2012. Generic companies like Dr Reddy's is trying to enter the original drug market. Under current laws, the first applicant(s) with a paragraph IV certification in their drug application is entitled a period of 180 days as market exclusivity. In Dr Reddy's case, Merck & Co. did not file a patent infringement case within 45 days of being notified by the generic firm, which means there are no blocking patents preventing FDA from approving its application.

      But since another generic company filed a generic drug application for Fosamax Plus D in November 2007, 12 months ahead of Dr Reddy’s application (filed in November 2008), technically the Hyderabad-based company is not the first applicant. Dr Reddy's believes the first applicant has apparently forfeited its 180-day exclusivity eligibility since, according to information posted on FDA's drug approval database, the agency has not tentatively approved any generic drug of Fosamax Plus D.

      In June Dr Reddy's requested FDA's office of generic drugs (OGD) to grant expedited review to its generic drug application which would allow it to enter the market early. But FDA's office of drugs declined its request.

      "Amending Manual of Policies and Procedures to permit OGD to grant expedited review in situations, where there are no blocking patents because a generic applicant was not timely sued for patent infringement and where 180-day exclusivity has been lost or forfeited, is consistent with current OGD policy and with a principal policy goal of the Hatch-Waxman Amendments — that is, to ensure the expedited approval of safe and affordable generic drugs," said Kumar Sekar, senior director (Regulatory Affairs and Compliance). Under FDA's current policy, expedited review is available for a first generic product for which there are no blocking patents.

      Sep 13, 2010


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