Dr Reddy's to launch AmVaz's generic version

By siliconindia   |   Thursday, 26 February 2004, 08:00 Hrs
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HYDERABAD: Having suffered a temporary setback in the branded segment in the US markets after the USFDA’s decision to hold the approval for AmVaz, Dr Reddy’s Laboratories has decided to launch its generic version for which it has filed an Abbreviated New Drug Application (ANDA) with USFDA for Amlodipine Besylate tablets 2.5, 5 and 10 mg, with a Paragraph IV certification on the two Orange Book patents listed for the drug.

Dr Reddy’s has notified Pfizer, upon which the latter filed a lawsuit against the company in the US district court for the district of New York alleging patent infringement on the two Orange Book patents, according to the company’s press release issued on Tuesday. Amlodipine Besylate is the generic version of Pfizer’s Norvasc and is indicated for the treatment of hypertension and angina. The brand had annual sales in the US of approximately $2bn.

Early this month, USFDA told Dr Reddy’s that the approval for its drug for hypertension and angina, AmVaz (API-Amlopdipine Maleate), would be on hold pending a re-evaluation.

The FDA’s letter indicated that the re-evaluation was prompted by questions raised about the source of the data relied on by FDA in its review and the agency would stay the approval for AmVaz pending the expedited re-evaluation.




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