(Reuters) Feb 27 - U.S. health regulators have rejected a vaginal gel from Watson Pharmaceuticals and Columbia Laboratories aimed at reducing the risk of premature birth, the companies said on Monday.
The Food and Drug Administration told the companies that the data was not strong enough to support approval of the Prochieve drug and that they needed to do additional clinical studies, Watson and Columbia said.
The decision was not a major surprise after an advisory panel to the FDA recommended in January that the agency reject the drug, already used in some other countries, because there was not enough data to show it worked.
The vaginal gel, which contains the hormone progesterone, is meant for women with a short cervix, who have a higher risk of premature birth.
"We have formally requested an end-of-review meeting with FDA to determine if a viable path forward can be established for this application," Watson Chief Executive Officer Paul Bisaro said in a statement.
A similar drug called Makena, from K-V Pharmaceutical Co, is already approved in the United States to prevent premature birth in women who have a history with the condition. But there is currently no other drug approved for women with a short cervix, who may be at higher risk of preterm birth but have never had problems before.
In a preliminary review of the gel, FDA staff said Prochieve did not work as well for women in the United States, and the drug's overall success may have been influenced by high performance in countries such as Belarus and South Africa.
The rejection is a setback for Watson, which is one of the world's biggest generic drugmakers and is also developing a brand-name pharmaceutical franchise in men's and women's health products.
Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such
Comments
Post a Comment