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ATHENS, Ga. — A drug used to treat high cholesterol, which will lose patent protection and face generic competition starting this year, also may help prevent blindness in people with diabetes, according to a study by researchers at the University of Georgia.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

The FDA announced the approval of Corifact, used to prevent bleeding in people with the genetic disorder congenital Factor XIII deficiency, which affects 1-in-3 million to 5 million people in the United States.

The drug is manufactured by Marburg, Germany-based CSL Behring.

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

PRINCETON, N.J. — The Food and Drug Administration has approved a psychiatric drug for treating bipolar disorder when used in combination with one of two other drugs.

The FDA approved Abilify (aripiprazole), made by Bristol-Myers Squibb and Otsuka Pharmaceutical, as an adjunct to lithium or valproate for maintenance treatment of bipolar I disorder.

SILVER SPRING, Md. — The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

The FDA announced the seizure of about $16.5 million worth of Auralgan otic solution made by Brooks, Ky.-based Integrated Commercialization Solutions. Chapel Hill, N.C.-based Deston Therapeutics manufactures the drug, while ICS warehouses it.

EAST BRUNSWICK, N.J. — Savient Pharmaceuticals announced changes to its management team as it gears up for the commercial launch of its chronic gout treatment.

The drug maker appointed Louis Ferrari as its SVP corporate development, Christine Mikail as SVP and Stephen Davies as chief information officer and group VP.