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Generics

  • Impax, Banner to develop two softgel capsule products

    HAYWARD, Calif., and HIGH POINT, N.C. — Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

    Impax said it has entered a deal with Banner Pharmacaps in respect to the supply and commercialization of two softgel capsule products.

    The products and terms of the agreement were not disclosed.

  • Watson faces patent challenge over generic Vigamox

    PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

    Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

  • Elite's generic Adipex-P enters market

    NORTHVALE, N.J. — Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

    The drug maker announced the initial shipment of phentermine hydrochloride tablets in the 37.5-mg strength. The drug is a generic version of Teva’s Adipex-P.

    Adipex-P and generic versions had sales of about $40 million in 2010, according to IMS Health.

    The shipment was made under a collaborative agreement with precision dose and its subsidiary, TAGI Pharma.

  • Salix, Lupin ink technology deal for Xifaxan

    RALEIGH, N.C. — Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

    Under the deal, Salix will receive exclusive worldwide rights for Xifaxan (rifaximin) drug technology developed by Lupin and jointly by both companies in all countries except India.

    Salix is required to pay Lupin $10 million upfront, as well as potential payments related to regulatory milestones.

  • Shire files lawsuit against Watson over Adderall XR

    DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

    Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

  • Bioniche Pharma launches generic Sandostatin

    PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

    Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

  • Takeda tries to block Impax's launch of generic Dexilant

    HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

    Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

  • Intellipharmaceutics seeks to market generic Seroquel XR

    TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

    Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

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