c*********7 发帖数: 19373 | | p********e 发帖数: 1960 | 2 Thanks...Metal brother called earlier...
target 5?
【在 c*********7 的大作中提到】 : 现在上应该也还好,今天在拉升。
| y*****l 发帖数: 5997 | 3 sppi 最近要炒FDA吗?
Spectrum Pharmaceuticals Responds to FDA's Complete Response Letter for
Fusilev
Sunday 11/07/2010 1:04 AM ET - Close-up Media
Spectrum Pharmaceuticals, a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in oncology,
announced that on Friday, October 29, it submitted a complete response to
the "Complete Response" letter issued by the U.S. Food and Drug
Administration (FDA), regarding its supplemental New Drug Application (sNDA)
for Fusilev (levoleucovorin) for Injection for treatment of patients with
advanced metastatic colorectal cancer.
"We believe that the additional data we submitted will satisfy the
requirements of the FDA," said Rajesh C. Shrotriya, MD, Chairman of the
Board of Directors, Chief Executive Officer, and President of Spectrum
Pharmaceuticals. "We continue to expect a favorable regulatory decision."
The Company said the FDA requested additional data in support of the its
sNDA filing for Fusilev's use in advanced metastatic colorectal cancer,
which has now been submitted. FDA has up to 60 days to formally accept the
submission.
According to a release, Fusilev is currently FDA approved and marketed by
Spectrum for rescue after high-dose methotrexate therapy in osteosarcoma.
Fusilev is also indicated to diminish the toxicity and counteract the
effects of impaired methotrexate elimination, and of inadvertent overdosage
of folic acid antagonists.
Spectrum noted that Fusilev, a novel folate analog, is available in vials as
freeze-dried powder. Fusilev rescue is indicated after high-dose
methotrexate therapy in osteosarcoma. Fusilev is also indicated to diminish
the toxicity and counteract the effects of impaired methotrexate elimination
and of inadvertent overdosage of folic acid antagonists. Fusilev has been
marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and
others for more than 10 years.
Fusilev is contraindicated for patients who have had previous allergic
reactions attributed to folic acid or folinic acid. Due to calcium content,
no more than 16-mL (160-mg) of levoleucovorin solution should be injected
intravenously per minute. Fusilev enhances the cyto-toxicity of fluorouracil
. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for
pneumocystis carinii pneumonia in HIV patients was associated with increased
rates of treatment failure in a placebo-controlled study. Allergic
reactions were reported in patients receiving Fusilev. Vomiting (38 percent)
, stomatitis (38 percent) and nausea (19 percent) were reported in patients
receiving Fusilev as rescue after high dose methotrexate therapy. Fusilev
may counteract the antiepileptic effect of phenobarbital, phenytoin and
primidone, and increase the frequency of seizures in susceptible patients. | D****9 发帖数: 10889 | | a****b 发帖数: 3588 | |
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