RAPS

FDA finalizes ANDA CRL, Orange Book Q&A guidances

The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications ...
FiercePharma

FTC claims a win as Teva moves to delist hundreds of patents from FDA Orange Book, agency says

For more than two years, the U.S. Federal Trade Commission (FTC) has been taking certain drugmakers to task over their alleged listing of "improper" patents in an FDA registry, a practice the agency ...
RAPS

FDA Offers First Major Update to ‘Orange Book’ Website

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the ...
JD Supra

Branded Manufacturers Decline to Remove Patents From the Orange Book After Receiving Letters From the FTC

On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes ...
JD Supra

Listing a Liability: The Orange Book’s New Antitrust Frontier

The tension between regulatory compliance and antitrust exposure in Orange Book patent listings reached a dramatic inflection point this fall. In late October, Teva Pharmaceuticals agreed to pay $35 ...