IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Nature of the Case and Issue(s) Presented: Salix holds NDAs for 200mg and 550mg Xifaxan. The 550mg strength product was approved to treat irritable bowel syndrome with diarrhea (“IBS-D indication”) and hepatic encephalopathy...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more
When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the...more