Skip to main content

New Products

  • FDA delays approval of GSK vaccine

    LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

    GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.

  • FDA approves Actavis drug for opioid dependence

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

    Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

    The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

     

  • Lilly, BI apply for diabetes drug approval

    RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

    BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

  • FDA approves Novartis antibacterial treatment for cystic fibrosis

    EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

    Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

  • Actavis can launch generic version of Crestor in 2016, under deal with AstraZeneca

    PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

    Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

  • U.K.'s Infirst Healthcare raises $30 million-plus to feed European OTC cough-cold and analgesic launches

    LONDON — The U.K.'s Infirst Healthcare on Monday announced it has successfully raised $32.1 million in new funds. The funding, from Invesco Asset Management managed funds, will be used for the launch of the company's medicines into the cough-cold and analgesic consumer healthcare markets.

  • SanMedica unveils new HGH-booster at Academy of Women's Health's Annual Congress

    WASHINGTON —  SanMedica International on Friday introduced its SeroVital-HGH, a new oral human-growth hormone booster formulated with women in mind, at the Academy of Women's Health's Annual Congress here. 

  • Ben & Jerry's adds newest flavor

    BURLINGTON, Va. — Ben & Jerry's announced today the addition of Chocolate Peppermint Crunch ice cream to round out the company's 2013 lineup of new full-time options.

    Chocolate Peppermint Crunch is a chocolate ice cream laced with swirls of peppermint and fudge and mint cookie pieces mixed in.

    Chocolate Peppermint Crunch joins other 2013 full-time flavors, such as:

X
This ad will auto-close in 10 seconds