SFDA releases approval status of HIV, cancer, Alzheimer's drugs, GBI

Release Date: 2009-09-09

The State Food and Drug Administration (SFDA) announced the current approval status for public health-related drugs as well as drugs to treat serious diseases such as HIV and cancer, according to Chinanews.com.cn September 8.

Two imported HIV drugs, raltegravir (Isentress by Merck Sharp & Dohme) and etravirine (Intelence from Johnson & Johnson Pharmaceuticals) received SFDA market approval this year. Two domestic HIV drugs, a lamivudine tablet and a lamivudine, zidovudine, and nevirapine combination were approved to enter clinical trials this year.

Anti-tumor drugs sorafenib (Nexavar by Bayer Healthcare), sunitinib (Pfizer's Sutent) and decitabine (Eisai's Dacogen) were all granted market approval without undergoing clinical trials under the SFDA's special approval pathway policy that provides patients with earlier access to serious disease treatments.

GlaxoSmithKline's imported zanamivir inhalant (Relenza) and domestically manufactured H1N1 influenza vaccines have all been granted approval for the prevention and control of H1N1 influenza.

Additionally, in the first half of 2009, domestically produced donepezil hydrochloride tablets received approval to undergo clinical trials for severe Alzheimer's disease treatment.
Type: NORMAL
Company: GBI
Country: China
Url: http://www.gbipharma.com/cpbheadline.asp?newsid=2010541
 
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