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Regulatory and Washington

  • Par acquires rights to generic version of Seroquel XR

    WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.

  • Watson launches generic version of Actos

    PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

    Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

  • Vast majority of online pharmacies are fly-by-night operations, report finds

    MOUNT PROSPECT, Ill. — About 97% of online pharmacies are "rogue" operations operating outside U.S. laws and regulations, according to a new report.

  • GelStat updates SEC filings, positions for future growth

    PALM CITY, Fla. — GelStat is primed to grow its OTC remedy business, according to a letter to shareholders and prospective investors released Tuesday. 

  • FDA approves Teva's Synribo for blood and bone marrow cancer

    SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

    The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

  • FDA cracks down on violators of dietary supplement regulations

     SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations. 

    A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

  • Novartis outsources production to bring back top-selling OTC brands to market

     BASEL, Switzerland — Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic. First shipments to retailers were made in October. 

  • FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths

    SILVER SPRING, Md. — The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

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