FDA approves expanded use of antipsychotic drug
ADELPHI, Md. An advisory committee of the Food and Drug Administration has voted that a drug used to treat bipolar disorder and schizophrenia is safe for use in teenagers.
Indianapolis-based drug maker Eli Lilly & Co. announced that the FDA’s Psychopharmacologic Drugs Advisory Committee voted that Zyprexa (olanzapine) is effective and acceptably safe for treating schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents, ages 13 to 17.
“This committee of experts spent two days discussing the science of a difficult topic being debated in the media, doctors’ offices and living rooms across the country,” Lilly Research Labs VP John Hayes said. “Today’s committee vote is an important step toward providing help and hope to the many teens suffering from severe mental illness.”
The committee voted 11 to five with two abstentions for the schizophrenia indication and 10 to four with four abstentions for the bipolar disorder indication. FDA advisory committees’ votes do not grant approval to drugs, but they are taken into consideration when the FDA decides whether to approve a drug.
Senate to vote on drug importation measure
WASHINGTON U.S. Sen. Byron Dorgan, D-N.D., has dropped his proposal to add the importation of cheaper medicines from other countries to a tobacco legislation.
Dorgan claims that under the amendment, the Food and Drug Administration would be given the power to oversee packaging, marketing and manufacturing of cigarettes and other tobacco products, Reuters reported. Additionally, U.S.-licensed pharmacies and drug wholesalers would also be allowed to import FDA-approved medicines from Canada, Europe and a few other areas for cheaper prices.
The Senate will consider the drug issue separately, Reuters said.
President Barack Obama has asked Congress for $5 million for the FDA to get started. Despite presidental backing, drugmakers are unhappy with Dorgan’s bill, claiming that with importation comes the risk for counterfeit drugs.
The tobacco bill passed the Senate on Monday with a 61-30 vote and proceeds to legislation later this week.
KV Pharmaceuticals, Purdue Pharma settle OxyContin dispute
ST. LOUIS A generic drug company has settled a dispute with a branded drug company concerning the painkiller OxyContin.
St. Louis-based KV Pharmaceutical Co. announced Tuesday that it had entered a settlement agreement with Stamford, Conn.-based Purdue Pharma in a patent infringement lawsuit that Purdue filed against KV.
Under the terms of the agreement, KV agreed that Purdue’s patents for OxyContin (oxycodone hydrochloride) are valid, enforceable and infringed. In exchange, Purdue granted KV limited rights to sell generic controlled-release oxycodone hydrochloride tablets in the United States for an unspecified period of time.