Generic 180-Day Exclusivity Forfeiture: What If “Failure” Is Not Your Fault?
Executive Summary
A generic drug firm at risk of losing 180-day exclusivity for a product because of FDA's new forfeiture triggers may have some legal remedies beyond those already tried against the agency
You may also be interested in...
Citizen Petitions On Generic Carve-Outs May Be Whittled Away By FDAAA
FDA and the generics industry are cautiously optimistic that reforms included in the FDA Amendments Act of 2007 will reduce the approval delays that generics have experienced due to citizen petitions
Citizen Petitions On Generic Carve-Outs May Be Whittled Away By FDAAA
FDA and the generics industry are cautiously optimistic that reforms included in the FDA Amendments Act of 2007 will reduce the approval delays that generics have experienced due to citizen petitions
180-Day Exclusivity Decision On Acarbose Illustrates Importance Of ANDA Quality
FDA's decision to deny Cobalt 180-day exclusivity for its ANDA of acarbose (Bayer's diabetes treatment Precose) illustrates the importance for generic firms of submitting high-quality applications