FDA announces likely delay on Novo Nordisk diabetes drug
WASHINGTON The Food and Drug Administration has announced that it will be unable to meet the user fee deadline for a timely approval of Novo Nordisk’s drug liragludite.
The FDA will not be able to make an approvability decision until March 23 for the drug, a treatment for Type 2 diabetes. Novo Nordisk had submitted an approval application for the drug on May 23.
The standard review period for FDA action on approval applications is 10 months. Because the agency’s advisory committee meeting will take place shortly before March 23, however, its decision will probably be delayed by a further two months, the company said.
Generics to drive worldwide pharmaceutical growth
SAN JOSE, Calif. Growth in various sectors of the pharmaceutical industry is expected to come from Brazil, Russia, India and China the so-called B.R.I.C. countries according to a new report by Global Industry Analysts.
In the Asia-Pacific region in particular, government restrictions on healthcare spending and low discretionary spending power among the population is increasing sales of low-cost generic drugs, while China has emerged as a region with potentially vast opportunities for global marketplace majors.
Across various countries, the generic drugs market is seeing rapid growth thanks to the need for drugs that can save lives while remaining cost-effective. This is attracting multinational companies into production and marketing of generic versions of branded drugs. Many consumers in developing countries are gaining access to drugs previously out of bounds for them, though many of the drugs violate patents, according to the report, titled “Pharmaceuticals: A Growing Outlook.”
FDA panel votes in favor of Pfizer’s Fablyn
NEW YORK The benefits of Pfizer’s osteoporosis drug Fablyn outweigh its risks, a Food and Drug Administration panel said, recommending the drug for postmenopausal women in a 9-3 vote Monday.
The advisers on the panel said they could not determine whether deaths among patients using the drug were a statistically significant increase over deaths among those receiving a placebo.
But, they said, the decision was neither a clear rejection of the drug nor a clear endorsement.
Pfizer had maintained that numbers showing an increase in deaths among patients using the drug, known generically as lasofoxifene tartrate, were not statistically significant.