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  • Pfizer sues to protect Viagra from generic competition

    NEW YORK — Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday. 

    Torrent has filed an aNDA with the Food and Drug Administration, challenging Pfizer's patent that expires on Oct. 22, 2019. 

  • Mallinckrodt receives FDA approval for Xartemis XR

    DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

    The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.

  • FDA approves Eliquis for DVT prophylaxis

    PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.  

  • National Safety Council outlines seven startling facts about Rx painkillers

    ITASCA, Ill. — In observance of National Poison Prevention Week, which is March 16 to 22, the National Safety Council has released a list of facts many people do not — but need to — know about prescription painkiller use. Did you know? 1. Forty-five people die every day from opioid prescription painkillers — more deaths than heroin and cocaine overdoses combined; 2. In 2010, enough prescription painkillers were provided to medicate every American around the clock for an entire month;

  • FDA approves Upsher-Smith's Qudexy XR extended-release capsules

    MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

    Qudexy XR will be available to patients in second quarter 2014.

  • IRI shares best practices for Rx-to-OTC switch

    CHICAGO and ORLANDO, Fla. — Prescription and over-the-counter products are often the first remedy consumers turn to when seeking relief from such conditions as allergies and heartburn, according to IRI. In its latest report, "Best Practices for Rx-to-OTC Product Launches," the company offers some tactics to help drive success for companies looking to execute the category switch.

  • Report: Maryland bill could create hardships for Rx wholesale distributors

    WASHINGTON — A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

  • Aerocrine AB: Primary care trial supports FeNO-guided asthma treatment

    SOLNA, Sweden — Aerocrine AB, a medical products company focused on improved management and care of patients with such inflammatory airway diseases as asthma, has announced that a new randomized clinical trial shows lower incidence of asthma exacerbations and increased asthma control with Fractional exhaled Nitric Oxide (FeNO)-guided anti-inflammatory treatment.  

    The study has been published on theweb site of the Journal of Allergy and Clinical Immunology: In Practice.

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