Eli Lilly resubmits supplemental approval application for Cymbalta
INDIANAPOLIS Drug maker Eli Lilly & Co. has resubmitted a supplemental approval application with the Food and Drug Administration for the use of a drug to treat chronic pain, after withdrawing it late last year.
The Indianapolis-based drug maker originally submitted the supplemental new drug application for Cymbalta (duloxetine hydrochloride) in the second quarter of last year, but withdrew it in November due to problems with the study design and statistical methodology.
The resubmission is based on a study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain, the company said.
“The additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission,” Lilly Research Laboratories VP John Hayes said. “We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application.”
Par ships first generic version of J&J drug
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.
FDA creates transparency taskforce
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.