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Generics

  • AAM unveils push for CREATES Act passage

    WASHINGTON — The Association for Accessible Medicines has rolled out a new video and infographic in support of its campaign for patients to call on their representatives to support legislation supporting the generics industry. The materials outline AAM’s case for passing the Creating and Resorting Equal Access to Equivalent Samples Act.

  • Lupin gets FDA approval for Vibra-Tabs generic

    SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s generic of Pfizer’s Vibra-Tabs (doxycycline hyclate) tablets. The drug is indicatd to treat infections caused by various microorganisms and as an adjunctive therapy for severe acne.

    Lupin’s generic will be available in 100-mg dosage strength. The drug had U.S. sales of $149.9 million for the 12 months ended June 2017, according to QuintilesIMS data.

  • Teva names new president, CEO

    JERUSALEM — Teva has a named its next leader. The company on Monday announced the appointment of Kåre Schultz as its president and CEO, who will take over the position from Dr. Yitzhak Peterburg.

  • Sanofi gets tentative FDA approval for Humalog follow-on Admelog
    SILVER SPRING, Md. — The Food and Drug Administration recently granted tentative approval to Sanofi’s Admelog (insulin lispro injection, 100 units/ml), a rapid-acting human insulin analog. The drug, a follow-on biologic version of Lilly’s Humalog, is indicated to improve glycemic control in patients with diabetes. 
     
    The approval means that Admelog has met all requirements for the regulatory agency, pending any patent issues that have not yet been resolved. 
     

  • Dr. Reddy’s launches Wellbutrin XL, Skelaxin generics

    HYDERABAD, India, and PRINCETON, N.J. — Dr. Reddy’s Laboratories has introduced two generics this week. The company on Wednesday announced the launch of its generics of Wellbutrin XL (bupropion hydrochloride) extended-release tablets and Skelaxin (metaxalone) tablets.

  • Lupin launches generic Fosrenol chewable tablets

    MUMBAI and BALTIMORE — Lupin has introduced its generic of Fosrenol (lanthanum carbonate) chewable tablets. The company’s alliance partner, Natco, had previously received approval for the tablets from the Food and Drug Administration.

    The drug is indicated to reduce serum phosphate in patients with end-stage renal disease. Lupin’s generic will be available in 500-, 750- and 100-mg (base) dosage strengths.

    The product had an estimated market size of $122.4 million, according to QuintilesIMS data for the 12 months ended June 2017. 
     

  • Dr. Reddy’s intros Suprax generic

    HYDERABAD, India, and PRINCETON, N.J. — Dr. Reddy’s Laboratories has introduced its generic of Suprax (cefixime for oral suspension). The drug is indicated to treat various bacterial infections.

    The Dr. Reddy’s generic will be available in 100 mg/5 ml and 200 mg/5 ml dosage strengths after reconstituion. The 100 mg/5 ml dosage strength is available in 50-ml bottles and the 200 mg/5 ml strength is available in 75- and 50-ml bottles.

  • Lupin’s generic Benicar launches

    Lupin’s generic Benicar launches

    MUMBAI and BALTIMORE — Lupin on Monday launched its generic of Benicar (olmesartan medoxomil) tablets, having earlier received approval from the Food and Drug Administration. The drug is indicated to treat hypertension, alone or in combination with other hypertensive agents, to lower blood pressure.

    Lupin’s generic will be available in 5-, 20- and 40-mg dosage strengths. The drug had U.S. sales of $681 million for the 12 months ended July 2017, according to QuintilesIMS data. 

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