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…the Court had deemed arbitrary and capricious. On remand, agencies are permitted to come to the same conclusions as they had come to in the first instance, as long as…
…the revised Agreement, otherwise their existing Agreement will be terminated. The final NDRA contains only minor changes from a draft that CMS issued for comment on November 9, 2016, which…
…83 Fed. Reg. 12027, 12028 (Mar. 19, 2018). The Acting Administrator noted that there was no evidence in the record as to when the doctor received the OSC. As such,…
…Inc.’s SUBOXONE (buprenorphine and naloxone) Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg (approved under NDA 022410); specifically Dr. Reddy’s Laboratories, Inc. ANDA…
…if a non-infringing alternative exists. Momenta Pharms., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. Aug. 3, 2012), the Federal Circuit explained that the safe harbor will still…
…on August 17, FDA issued draft guidance, “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.” The short, seven-page guidance is intended, according…
…approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release Tablets, 500 mg. In January 2008, the U.S. District Court for the District of Columbia…
…after June 29, 2001, and no later than July 20, 2001, the date of the next database update.” As such, “at the time Teva submitted its ANDA, the electronic Orange…
…challenging to identify discrete opportunities. However, we believe those companies facing near term generic competition have the strongest motivation to consider this strategy in order to capture residual intellectual property…
…user fees. Thus, for such companies, FDA’s costs remain static while the total amount of fees paid by the company continues to grow, eventually leading to an overage. The FDA…
…of Illinois (Eastern Division) in Abbott Labs. v. Matrix Labs., Inc., No. 09-cv-1586 (N.D. Ill. Nov. 5, 2009) ordered the tolling of the 30-month stay in the context of patent…
…decision, the district court denied Cody/Lannett’s Motion for Temporary Restraining Order and Preliminary Injunction. Cody/Lannett then filed, FDA opposed, and the court granted, a Motion for Clarification, Amendment, or Reconsideration…
…five chemicals, JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol, are used to make “fake pot” products. These “smokable herbal blends” have been marketed as being legal substances, and have been increasing…
…rule back to DoD to decide whether to maintain the current rebate/refund program in effect since May 26, 2009, or implement some other mechanism for obtaining FCPs. Not surprisingly, after…
…appears that bis-(p-hydroxyphenyl)-pyridyl-2-methane (BPHM, CAS: 603-41-8, UNII: R09078E41Y), the active moiety of sodium picosulfate (CAS: 10040-45-6, UNII: VW106606Y8), also seems to be the active moiety in bisacodyl [(4,4’-diacetoxydiphenyl(2-pyridyl)methane), CAS: 603-50-9,…