FDA approves Seroquel for adolescents
WILMINGTON, Del. An advisory committee of the Food and Drug Administration has given a positive review to an AstraZeneca drug used to treat schizophrenia and bipolar disorder.
The Anglo-Swedish drug maker announced that the FDA’s Psychopharmacologic Drugs Advisory Committee had given favorable review to its supplemental approval application for Seroquel (quetiapine fumarate). AstraZeneca is seeking approval for the drug as a treatment for schizophrenia in adolescents ages 13 to 17 and bipolar mania in children and adolescents ages 10 to 17.
“We are pleased that the committee found Seroquel to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with biopolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs,” AstraZeneca chief medical officer Howard Hutchinson said in a statement, referring to the company’s supplemental new drug applications.
The same day the advisory committee made its decision about Seroquel, it also voted in favor of Eli Lilly & Co.’s Zyprexa (olanzapine) as a treatment for schizophrenia and bipolar episodes in adolescents, ages 13 to 17.
The committee’s decisions do not constitute approval, but the FDA takes them into consideration when deciding 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.