Skip to main content

FDA Rejects Watson/Columbia Premature Birth Gel

(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.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

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...
Post a Comment
Read more

FDA Decision Delayed for Truvada in HIV PrEP

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine ( Truvada , Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed. In early May, the FDA's Antiviral Drugs Advisory Committee  strongly backed  approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection. However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended. According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug. The committee's recommendation for supplemental approval of tenofovir/emtricit...
Post a Comment
Read more

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...
Post a Comment
Read more