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…or biotechnology industries. Indeed, 2015 may be a record-breaking year for such deals (see here, here, and here). Whether we’re talking about generic-on-generic, brand-on-brand, or brand-on generic acquisitions, however, there…
…2013 petition to FDA. UPDATE: May 9, 2014: The following Minute Order was entered: MINUTE ORDER denying plaintiffs’ motion for a temporary restraining order. For the reasons stated on the…
…the question of whether dietary compliance, and therefore patient health, will benefit from a medical food should be left to the medical community, not to FDA. Indeed, this approach amounts…
…§ 45a does not extend to online and mail order claims as that provision refers to product labels, not to other labeling or advertising. Comments may be submitted until 60…
…Register, a meeting of a device classification panel … and consideration of comments to a public docket.” FDASIA, § 608(a). Why is issuing a proposed order for notice and comment…
…questioned the facility’s decision to release certain products into commerce: Your facility distributed at least a portion of eight (8) lots of peanut and almond butter… after composite testing of…
…August 6, 2015 Order dismissing for lack of personal jurisdiction patent infringement litigation timely initiated by Purdue. (We say “appears” because the court’s Order is not expressly characterized as vacating…
…a substantive review of the submission in order to complete the RTA checklist (thus, making the RTA more than an administrative check of completeness). Based on the RTA comments we…
…Complaint ¶ 62. 6. Controlled Substances Received from Multiple Providers Individuals presenting controlled substance prescriptions from multiple prescribers may indicate “doctor shopping.” Providers should be aware of the other drugs…
…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…
…(H.R. 6160) – that is intended to direct companies “to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature…
…MMA Staddle drug products include Topiramate Sprinkle Capsules, 15 mg and 25 mg (TOPAMAX) and Methylphenidate HCl Extended-Release Tablets, 18 mg, 27 mg, 36 mg, and 54 mg (CONCERTA). Also…
…180-day generic drug and pediatric exclusivity issues involving NORVASC (amlodipine besylate) Tablets and the availability of generic versions of the drug product. Mylan’s amlodipine drug product is the only generic…
…FDA-approved Over-the-Counter (“OTC”) drug MUCINEX (guaifenesin) Extended-Release Tablets, also marketed under the trade name HUMIBID. (You know, the drug product in those ubiquitous “Mr. Mucus” commercials.) However, that enforcement action…
…post-regulatory history of homeopathy is too long and too complex to cover here, but for an excellent review of this history, read Dr. Susan White Junod’s “An Alternative Perspective: Homeopathic…