GTx seeks approval for prostate cancer drug
MEMPHIS, Tenn. GTx has submitted an approval application to the Food and Drug Administration for a drug to prevent bone fractures in prostate cancer patients using androgen deprivation therapy, the Memphis, Tenn.-based drug maker announced Tuesday.
The drug, toremifene, is an oral selective estrogen receptor modulator. The company wants to make the drug available in the 80 mg strength.
“[Androgen deprivation therapy] has helped improve survival for men with advanced prostate cancer,” GTx chief executive officer Mitchell Steiner said in a statement. “Unfortunatley, ADT may cause unintended serious estrogen deficiency side effects, such as high risk of fractures, which can shorten survival.”
Steiner said that toremifene would be the first cancer care agent for preventing fractures in men receiving ADT if approved.
Ipsen has licensed European rights for toremifene from GTx and will submit an approval application in 2009.
A phase 3 trial of 1,382 prostate cancer patients receiving ADT indicated that toremifene reduced morphometric vertebral fractures compared to placebo. GTx has requested priority review from the FDA for toremifene due to the lack of a drug for decreasing bone fractures in patients receiving ADT.
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.