China-made pill close to get America`s FDA nod
Beijing: A China-made pill to treat cardiovascular conditions has been tested safe and effective by the US Food and Drug Administration and it could be marketed in America as early as 2013, a pharmaceutical company said here.
Tianjin-based Tasly Pharmaceutical`s Compound Danshen Dripping Pill had passed the US FDA`s Phase II clinical trials in July, one step closer to getting into the US and European drug market, the company`s president Yan Xijun said.
Clinical trials of the drug, composed of herbal extracts, was conducted in 15 test centers in the US over the last three years and had "generated positive results," Xinhua
news agency quoted Yan as saying.
With domestic sales of more than one billion yuan (about USD 148 million) last year, the drug was the first Chinese patent traditional medicine to pass Phase II trials of
the FDA, known for its strictness in approving drugs.
The FDA has also approved the drug to enter the Phase III trials, Yan said.
FDA Phase II trials gauge the effectiveness of a drug and its side effects and risks, while Phase III trials are more extensive.
Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug in the US.
Yan said the Shanghai-listed Tasly would build 50 to 70 clinical trial centers worldwide in the next 12 to 18 months for the Phase III trials, adding that he expected the
pills to enter US and global drug markets within three years.
Compound Danshen Dripping Pill is mainly used to treat angina and coronary heart diseases.
Already more than 10 million people worldwide take the pills annually, according to Tasly Pharmaceutical.
Previously, the drug had been approved by drug watchdogs in Canada, Russia, Republic of Korea, Vietnam, Singapore and some African countries.