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    Month: February 2009

    • Yet Another Petition is Submitted to FDA Concerning the QI Act & 30-Month Stay Availability; Latest Petition Concerns CELLCEPTFebruary 27th, 2009

      By Kurt R. Karst –       Over the past few weeks, we have posted (here and here) on citizen petitions submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version …

    • Obama 10-Year Budget Blueprint Includes Initiatives For Medicare, Medicaid, FDAFebruary 26th, 2009

      By Cassandra A. Soltis & Alan M. Kirschenbaum –  Today the Obama Administration released a summary of its 10-year budget proposal  entitled “A New Era of Responsibility – Renewing America’s Promise.”  The document provides a high level outline of priorities – details reportedly will be released in April.  …

    • Guilty Pleas Announced in Adulterated Tomato Products CaseFebruary 26th, 2009

      By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal –    The U.S. Attorney for the Eastern District of California  (Sacramento) has announced guilty pleas by two individuals for fraudulent activities in connection with their distribution of tomato products.  Allegedly at the direction of her …

    • FDA Can’t Always Get What it Wants In Seafood HACCP CaseFebruary 26th, 2009

      By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal –    FDA has obtained summary judgment and an order of permanent injunction against a Minnesota seafood supplier that was found to have had an inadequate HACCP plan for more than three years, in violation of …

    • Ranbaxy’s Manufacturing Woes Deepen; FDA Invokes AIP Against Paonta Sahib FacilityFebruary 25th, 2009

      By Kurt R. Karst –       Earlier today, FDA announced that the Agency was taking the unusual step of invoking its Application Integrity Policy (“AIP”) against Ranbaxy Laboratories Limited’s (“Ranbaxy”) Paonta Sahib manufacturing facility in India.  FDA takes such regulatory action under the Agency’s AIP procedures …

    • FDA Issues Notice on Maximum Civil Money Penalty AmountsFebruary 24th, 2009

      By James P. Ellison – We previously reported on FDA's Federal Register notice adjusting its civil penalties for inflation and noted our prior posts on the new civil penalty authority given to FDA in the FDA Amendments Act.  As we explained in our earlier post, FDA's …

    • Federal Circuit Affirms a 30-Month Stay Extension for Generic EVISTAFebruary 24th, 2009

      By Kurt R. Karst –       In a rare move, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision extending a 30-month stay available under the Hatch-Waxman Amendments with respect to Teva Pharmaceutical USA, Inc.’s ANDA for a generic version of …

    • Medicis Citizen Petition Argues For 30-Month Stay Under the QI ActFebruary 20th, 2009

      By Kurt R. Karst –       We previously reported on a citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of DORYX (doxycycline hyclate) Delayed-Release Tablets, an …

    • FDA Stays the Course on NanotechnologyFebruary 19th, 2009

      By Ricardo Carvajal— During a session at the Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, senior FDA staff confirmed that the agency does not intend to issue regulations specific to products derived through nanotechnology, or to establish a definition …

    • Second Circuit Upholds NYC Regulation Mandating Calorie Disclosure in RestaurantsFebruary 18th, 2009

      By Ricardo Carvajal The Second Circuit Court of Appeals has rejected  the New York State Restaurant Association’s (NYSRA’s) challenge to a New York City Board of Health (NYC) regulation requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear …

    • DEA Proposes Placing of Tapentadol Into Schedule IIFebruary 18th, 2009

      By John A. Gilbert and Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a notice of proposed rulemaking to control Tapentadol as a schedule II substance under the Controlled Substances Act.  Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II, 74 Fed. Reg. 7,386  …

    • FDA Orphan Drug Designations Are On the RiseFebruary 17th, 2009

      By Kurt R. Karst –       2008 was a banner year for orphan drug designations.  FDA’s Office of Orphan Products Development (“OOPD”), which, since September 2007, has been under the leadership of Timothy Coté, M.D., M.P.H., designated a record 165 products for orphan (i.e., rare)  diseases …

    • Scattered Oxycodone Shortages ReportedFebruary 15th, 2009

      By John A. Gilbert & Larry K. Houck –       WMSN-TV Fox 47 of Madison, Wisconsin, recently reported that pharmacies are experiencing difficulty obtaining oxycodone to fill their patients prescriptions.  Oxycodone, a schedule II opioid painkiller, is indicated for patients suffering from moderate to severe pain.  …

    • State AGs Make Bayer’s Yaz DTC Advertising Subject to FDA Prior Approval; $20M in Corrective Advertising Also RequiredFebruary 12th, 2009

      By J.P. Ellison – Twenty-Seven Attorneys General have given FDA prior approval authority over Bayer’s Direct-to-Consumer (“DTC”) television and print advertising for its prescription oral contraceptive Yaz, and also required to company to run a $20 million corrective advertising campaign as part of a settlement agreements with …

    • FDA Announces First Class-Wide REMS for OpioidsFebruary 11th, 2009

      By Bill T. Koustas – On February 9, 2009, FDA (or “the Agency”) announced it has invited the sponsors of opioid drug products to a private meeting in March in order to begin the process of developing Risk Evaluation and Mitigation Strategies (“REMS”) that will …

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