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Generics

  • Watson seeks regulatory approval for generic Adderall XR

    PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

    British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

  • Par sees sales gains across all sectors

    WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

    Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.

  • Caraco, Sun to merge

    DETROIT — Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

    Sun, which already owns 75.8% of Caraco, will pay $5.25 per share for the remaining shares of Caraco that it doesn’t already own and make Caraco a private company.

    Sun originally made the going private offer in December, offering $4.75 per share for Caraco.

  • GPhA announces executive committee, board of directors

    ORLANDO, Fla. — The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

    The GPhA said Watson Pharmaceuticals president and CEO Paul Bisaro had been reelected as chairman for a second, one-year term. Also elected were Mylan Pharmaceuticals president Tony Mauro, as vice chairman; and Momenta Pharmaceuticals president Craig Wheeler, as secretary treasurer.

  • Perrigo files regulatory application for Taclonex generic

    ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

    Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

  • Prasco agrees to distribute authorized generic of Pentasa

    CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

  • Medco's Q4, fiscal-year sales rise

    FRANKLIN LAKES, N.J. — Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.

    Profits for the quarter were $378.5 million, a 10.8% increase over fourth quarter 2009, while profits for the year were $1.4 billion, an 11.5% increase over fiscal year 2009.

  • Hi-Tech Pharmacal receives market exclusivity for generic Neurontin

    AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

    Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

    The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.

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