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…the National Consumer League (the plaintiffs) claim that FDA’s delay of the menu label*]}*ing rule was illegal because it did not “rationally explain[] why it was changing its interpretation of”…
…With that approval, FDA issued a statement, titled “Impact of Exclusivity on Approval of Arymo ER.” FDA’s statement explains that although intranasal route of abuse clinical studies were conducted with…
…August 2009, ViroPharma continued its petitioning campaign to obstruct and delay the FDA’s generic approval review process.” Although “FDA disposed of ViroPharma’s challenges as being ‘unsupported’ and ‘lack[ing] merit,’” in…
…broader thematic divergence at play in the biologic paradigm. Citizen Petitions: Long, Late-Filed, and At-Last Denied Michael A. Carrier & Carl J. Minniti III, Rutgers Law School The pharmaceutical industry…
…serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.”…
…Mitigare without requiring the label to contain critical safety information that FDA previously stated was necessary for single-ingredient oral colchicine products. Second, FDA’s approval of Hikma’s application for Mitigare was…
…second lawsuit is filed by Lannett Company Inc. and Lannett Holdings, Inc. (collectively “Lannett”) challenging FDA’s recent rescission of Lannett’s ANDA 202750 for the oral chemotherapy drug Temozolomide Capsules, 5…
…by Amarin, the court also addressed Amarin’s general request for First Amendment protection for truthful and non-misleading off-label promotion. The court heavily relied on the precedent-setting analysis in Caronia, although…
…in the agency’s position regarding the requirements for the label*]}*ing of single-ingredient oral colchicine products. Takeda also argues that “FDA’s failure to enforce its own label*]}*ing requirements allowed [West-Ward] to…
…and efficacy on the Yasmin label, the Yasmin label cannot instruct (and the ANDA proposed label cannot induce infringement of) the method of use claimed in the ’652 patent. Channel*]}*ing…
…this matter will not merely serve a useful purpose in settling the legal relations at issue and affording relief from the underlying controversy, but is essential to doing so. There…
…labor case, but the Court’s decision affects most if not all federal agencies that have injunctive authority. The Court ruled unanimously that the traditional equitable requirements for obtaining an injunction…
…a prescription drug approved by FDA for patients undergoing coronary artery bypass graft using a cardiopulmonary bypass pump to prevent excess bleeding. Simpson alleged that Bayer violated the False Claims…
…Allergan, Inc. (“Allergan”) recently filed a Complaint against Watson Laboratories and Actavis Pharma alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan is seeking, among other things, a…
…so-called NCE-1 date of May 19, 2013. It also means that a timely filed patent infringement lawsuit within 45 days of the NDA holder/patent owner having received notice of a…