FDA approves Roche’s nucleic acid test that screens for HIV in donated blood
ROCKVILLE, Md. The Food and Drug Administration has approved Roche Molecular Systems’ Cobas TaqScreen MPX Test. The MPX test is the first nucleic acid test that screens for the presence of two types of HIV in donated blood plasma and tissue, the FDA said.
“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that the donated blood and tissue are free from infection, and providing better protection for patients,” FDA Center for Biologics Evaluation and Research director Jesse Goodman said in a statement.
The test detects nucleic acid from HIV-1 Group M, the most common strain of the virus, and hepatitis B and C. It also detects HIV-1 Group O and HIV-2, both of which are most common in Africa, but have shown up in the United States.
FDA tentatively approves Seroquel generic
JERUSALEM The Food and Drug Administration has given tentative approval to a generic version of AstraZeneca’s antipsychotic Seroquel.
Teva announced last Tuesday that the FDA had granted the tentative approval for generic Seroquel (quetiapine fumarate) in 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg strengths.
The branded version of the drug had sales of about $3.8 billion in the United States for the 12 months ending Sept. 30, according to IMS Health data.
Teva expects to receive final approval after resolving patent litigation with AstraZeneca.
Zerit generic gets FDA approval
PITTSBURGH The Food and Drug Administration has approved a generic version of Bristol-Myers Squibb’s Zerit by Mylan’s Indian subsidiary, Mylan announced Tuesday.
The FDA approved Matrix Labs? stavudine capsules USP in 15 mg, 20 mg, 30 mg and 40 mg strengths. The drug is an antiretroviral used to treat HIV infection in combination with other antiretroviral drugs. The branded version of the drug had sales of about $54 million in the 12 months ending Sept. 30, according to IMS Health data.
Mylan owns a 71.5% stake in Matrix.