US FDA cuts drug filing fee by 8%; hikes annual facility fees by over 12%

摘要

The US Food and Drug Administrator (FDA) has lowered the fee charged for generic drug applications by 8%. The new rates, applicable on companies from all nations, are effective from October 1 and will remain in force through September 30, 2015. This will benefit pharma companies such as Cadila, Dr. Reddy's, Glenmark, Sun, Ranbaxy and Lupin, which have significant presence in the US. The FDA is authorised to collect user fee to approve certain human generic drug products. These filings can be in two categories. Those for finished formulations or abbreviated new drug applications (ANDAs) and for active ingredients called drug master files (DMFs). The revised fee for ANDAs and DMFs stands at $58,730 (Rs. 35.2 lakh) and $29,370 (Rs. 17.6 lakh), respectively.