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…to Dismiss at 9, PhRMA v. Brown, No. 2:17-cv-02573 (E.D. Cal. Jan. 26, 2018) [hereinafter Memorandum]; see also Ex Parte Young, 209 U.S. 123, 157 (1908). In the present matter,…
…this fact by letter dated February 12, 2010. The completed NDA was then submitted on April 19, 2010, which is considered to be the NDA initially submitted date. Boehringer alleges…
…Part APP Pharmaceuticals, LLC’s (“APP’s”) appeal related to Judge Claude M. Hilton’s August 3, 2010 decision. Briefly, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000 under New Drug…
… RELATED READING: April 5, 2007 Orange Book Blog Post UPDATE: Earlier today, the U.S. District Court for the District of Columbia issued an order extending from April 11, 2007…
…the company’s reconsideration request. With respect to Apotex, FDA refers to a May 7, 2007 letter answer the Agency sent to the company. In that letter, FDA declines to immediately…
…The court’s order vacates the district court’s April 11, 2008 injunction and reverses the court’s order. Also, in a rather unusual move, the court issued its mandate on September 12,…
…not apply to certain fish imported from Vietnam, which, although not “catfish” as defined by the FDC Act, apparently are often marketed as such. Three years later, the Farm Bill…
…Endotec’s ankle and jaw implants, but not its knee implants, were exempt “custom devices.” On March 30, the Eleventh Circuit affirmed in part and reversed in part, concurring that the…
…295 days (“Tier 2” goals). The review of a PMA is completed if the agency issues an approval order, an approvable letter, a major deficiency letter, a not approvable letter,…
…in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.” [(Emphasis added)] “In this case, the drugs at issue…
…praised by several groups (see here, here, and here). As we’ve previously noted (see our posts here, here, and here), the availability of product sample for reference products under a restricted…
…here), Zogenix first sued Massachusetts Governor Deval Patrick and other Commonwealth officials after the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, took actions to combat…
…state in which the registrant is licensed: Charles Syzman, D.O., 81 Fed. Reg. 64937 (Sept. 21, 2016) Richard J. Settles, D.O., 81 Fed. Reg. 64940 (Sept. 21, 2016) Kevin L….
…denied Omnicare, Inc.’s motion for summary judgment in the ongoing qui tam case, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ). In their complaint, filed…
…that received exclusivity, regardless of any overlap with respect to the conditions of approval, and so, the FDA argues, because Aristada and Abilify Maintena have different active moieties, the agency…