A China-made pill to treat cardiovascular conditions had been tested safe and effective by the U.S. Food and Drug Administration (FDA) and hopefully would be marketed in the United States as early as 2013, its Tianjin-based pharmaceutical manufacturer, Tasly, said Saturday August 7.
The drug, called Compound Danshen Dripping Pill, passed the FDA's Phase II clinical trials in July. Once Phase III is completed, Tasly can ask for the FDA approval to market the drug in the United States.
In the United States for example, new drugs need to pass three phases of clinical trials before receiving FDA approval to enter the market.
Usually, Phase I tests a new drug or treatment in a small group of people. It lasts for some 12 months, focusing on the safety of the new drug when used in people.
Phase II trials gauge the effectiveness of the drug and its side effects and risks. It often needs 100 or more patients to join the tests and may take two to three years.
Phase III trials are even more extensive. They need several hundred to several thousand patients chosen randomly and take two to four years on average. These tests compare the new drug to the standard or best known drug when treating the same kind of illness.
Once Compound Danshen Dripping Pill passes Phase III trials, it will become the first Chinese traditional herbal drug to win FDA approval. (Source: Xinhua, Aug 8, 2010)..