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The FDA is prepared to "move swiftly" to approve applications for fixed-dose combinations of previously approved drugs to treat HIV, saying it expects to be able to expedite priority reviews and approve fast-track designations for such products.
Pfizer announced that the Austrian Patent Office has ruled that a claim in the company's basic patent covering the use of atorvastatin, the active ingredient in the cholesterol drug Lipitor, would be infringed on by Ranbaxy's generic version.
The Australia New Zealand Therapeutic Products Authority (ANZTPA) has begun a second phase of consultation on the proposed joint regulatory scheme and is asking for feedback.
The US based 40-year-old Drug Information Association (DIA) may start an Indian chapter and office by next year, considering the increased activities in the field of drug discovery and clinical trials in India.
Genta Incorporated announced that its lead anticancer drug, Genasense (oblimersen), has received Orphan Drug designation from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia.
China's national drug regulator has revoked the license of the maker of an antibiotic blamed for at least six deaths and dozens of illnesses, the official news agency said Monday.
Health experts have confirmed that the emergence of extremely drug-resistant tuberculosis (XDR-TB) poses a serious threat to public health, particularly when associated with HIV.