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Actavis Generics [1] (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan, Inc.) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
FTC v. Actavis, Inc., 570 U.S. 136 (2013), was a United States Supreme Court decision in which the Court held that the FTC could make an antitrust challenge under the rule of reason against a so-called pay-for-delay agreement, also referred to as a reverse payment patent settlement.
It was four months ago that a definitive agreement was announced in which Actavis would acquire specialty pharma manufacturer Warner Chilcott in an $8.5 billion, all-stock deal. The two companies ...
The other drug-related charge was a misdemeanor charge of distributing the unapproved drug Levothroid in violation of the Federal Food, Drug, and Cosmetic Act. Certain of the criminal activities were revealed with the help of whistleblowers, who received $14 million from the settlement. [11] [12] [13]
There is safe harbor for research conducted for "purely philosophical" inquiry, but research directed to commercial purposes has no safe harbor - unless the research is directed toward obtaining approval of the Food and Drug Administration (FDA) for introduction of a generic version of a patented drug (see Research exemption and Hatch-Waxman Act).
Avibactam is a non-β-lactam β-lactamase inhibitor [2] developed by Actavis (now Teva) jointly with AstraZeneca.A new drug application for avibactam in combination with ceftazidime was approved by the FDA in 2015 for treating complicated urinary tract (cUTI) and complicated intra-abdominal infections (cIAI) caused by antibiotic-resistant pathogens, including those caused by multidrug ...
In two major cases before the Supreme Court of the United States, Pliva Inc. v. Mensing, (564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), Lefkowitz succeeded in persuading the Supreme Court that because federal law absolutely demands that generic drugs precisely follow the FDA-approved labels of the related brand-name drug produced by another manufacturer ...