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Generics

  • Mylan wins summary judgment pertaining to generic Copaxone

    PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

    The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).

  • FDA rejects Teva's request to block Watson's generic Seasonique

    PARSIPPANY, N.J. — A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

    The U.S. District Court for the District of Nevada denied Duramed Pharmaceuticals’ request for an injunction to keep Watson’s generic version of the contraceptive Seasonique (levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg) and ethinyl estradiol 0.01 mg from being launched.

    Seasonique is made by Teva Women’s Health, the successor of Duramed.

  • Watson's nabumetone tablets get FDA OK

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

    The drug maker announced the approval of nabumetone tablets in the 500-mg and 750-mg strength. The drug is used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis.

    Nabumetone had sales of $58 million during the 12-month period ended in April, according to IMS Health.

  • Watson confirms patent challenge for generic Pataday

    PARSIPPANY, N.J. — Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

    Watson is seeking approval for olopatadine hydrochloride ophthalmic solution in the 0.2% strength. The drug, used to treat itching in the eye resulting from allergic conjunctivitis, is a generic version of Alcon’s Pataday.

  • Nasacort AQ generic enters market

    ALLEGAN, Mich. — Teva Pharmaceutical Industries has begun shipping a generic drug for allergies, partnering company Perrigo said Wednesday.

    Triamcinolone acetonide nasal spray is a generic version of Sanofi’s Nasacort AQ and is used to treat nasal symptoms of seasonal and year-round allergies in patients ages 6 years and older. The Food and Drug Administration approved the generic version of the drug in 2009. The generic was made by Barr Labs, which Teva acquired a few years ago.

  • Tradjenta now available in U.S. pharmacies

    INDIANAPOLIS — A new oral medication for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim has become available in pharmacies, the companies said Wednesday.

    Lilly and BI announced the availability of Tradjenta (linagliptin) in chain and independent pharmacies around the country.

  • Dr. Reddy's subsidiary confirms receipt of FDA warning letter

    HYDERABAD, India — The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

    The drug maker said Dr. Reddy’s subsidiary Industrias Quimicas Falcon de Mexico, in Cuernavaca, received an FDA warning letter based on a November 2010 inspection where the regulatory agency found a number of manufacturing problems.

    Dr. Reddy’s said it takes the warnings seriously and will respond to the FDA and work with the agency to resolve the problems.

  • FTC issues 'second request' to Teva, Cephalon over deal

    JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

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