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…citizen petition concerning the approval of generic LOVENOX.) Sanofi filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction the U.S. District Court for the District of Columbia late…
…The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning their regulatory compliance and enforcement activities accessible,…
…ANDAs. On March 3rd, Sun supplemented its Motion for a Temporary Restraining Order and a Preliminary Injunction motion. The following Minute Order was entered on March 3rd: “It is ORDERED that…
…pay-for-delay deals” reportedly involved a so-called “No-AG,” or no Authorized Generic, agreement under which a brand-name drug company agrees not to launch an authorized generic to compete with a generic…
…to waive into D.C. Bar). Compensation commensurate with experience. Excellent benefits package. Email resume to jwasserstein@hpm.com. For more information about the firm, see www.hpm.com. HP&M is an equal opportunity employer….
…receive a discount) at www.AmericanConference.com/Cosmetics, or contact Bolam Kim (B.Kim@americanconference.com) directly to attend. Please be sure to use discount code S10-866-866L16.S to register and receive 10% off the tuition fee. …
…generic levoleucovorin drug product. The Court issued an Opinion and Order affirming a May 27, 2015 summary judgment Decision from Judge Royce C. Lamberth of the U.S. District Court for…
…July 10, 2009 stay order – specifically, whether the July 10th order was intended to: (1) enjoin FDA from granting final approval to their applications; or (2) to enjoin Mayne…
…and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed patent use code for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on…
By Kurt R. Karst – Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and,…
…the first ANDAs for Ziprasidone HCl Capsules, 20 mg (base), 40 mg (base), 60 mg (base), and 80 mg (base), were submitted to FDA on February 7, 2005. Only one…
…the day: Step 1: Fix. Step 2: It. Step 3: FIXIT! That approach sums up the “Generic Drug Application Review Fairness Act of 2012” (H.R. 4332), which Rep. Frank Pallone,…
…earlier today answering the question: “Whether federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled.” FDA’s…
…Wyeth’s complaint: FDA’s decision to approve a generic formulation that lacks two inactive ingredients that are essential to the safe co-administration of Zosyn with LRS was wrong as a matter…
…company’s petition that: The inadequate treatment of sBCC can lead to serious complications for patients, including the growth of their cancer. In that light, . . . is critical that…