PHARMACY

AACE, ACE applaud nomination of first diabetic justice

BY Anna Mcgrath

JACKSONVILLE, Fla. The American Association of Clinical Endocrinologists and the American College of Endocrinology recognize judge Sonia Sotomayor’s nomination to Supreme Court despite challenges as a Type 1 diabetic.

If elected by the Senate, Sotomayor will be the first diabetic member of the Supreme Court. The AACE and ACE commend Sotomayor in overcoming the many challenges the illness imposes.

Sotomayor was nominated on May 26 by President Barack Obama.

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Par ships first generic version of J&J drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.

The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.

The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.

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FDA creates transparency taskforce

BY Alaric DeArment

ROCKVILLE, Md. After years of criticism, the Food and Drug Administration wants to take the tinting off its windows.

The agency announced Tuesday the creation of an internal transparency taskforce, headed by principal deputy commissioner Joshua Sharfstein, to find ways to make its decision making more transparent for the public while protecting confidentiality.

“Over the years, there have been complaints made about the FDA’s lack of transparency,” commissioner Margaret Hamburg said in a conference call with reporters Tuesday morning.

Hamburg said the taskforce would take comments from the public and stakeholders to find ways to make information about agency operations, recall information, enforcement and other activities more accessible. The agency will convene a public meeting on June 24 and another one in the fall and accept public comment through a docket until Aug. 7.

“The recommendations of the taskforce will allow us to more effectively implement the agency’s public health mission,” Hamburg said.

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