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Last updated on April 23, 2014 at 17:02 EDT

Latest 17-Hydroxyprogesterone caproate Stories

2013-06-19 23:19:35

McGuff Pharmaceuticals, Inc. (MPI) continues to pursue the approval of an Abbreviated New Drug Application (ANDA) for Hydroxyprogesterone Caproate Injection, USP 250mg/mL, 5mL, multiple dose vial; a generic version of Bristol-Myers Squibb´s drug formerly known as Delalutin. While McGuff Pharmaceuticals can not predict when the FDA will complete its review, MPI remains committed to bringing the drug product to market as quickly as possible. Santa Ana, CA (PRWEB) June 19, 2013 McGuff...

2013-02-14 00:21:42

March of Dimes Award Abstract at SMFM Meeting SAN FRANCISCO, Feb. 14, 2013 /PRNewswire-USNewswire/ -- In a study to be presented today at the Society for Maternal-Fetal Medicine's 33(rd) annual meeting, The Pregnancy Meeting(TM), researchers will report findings that suggest that 17P, a form of progesterone, is not effective in preventing preterm birth among women with twin pregnancies -- and may possibly be harmful. (Logo: http://photos.prnewswire.com/prnh/20130214/DC59689LOGO) While...

2013-02-11 13:33:21

March of Dimes Award abstract In a study to be presented on February 14 between 8 a.m. and 10 a.m. PST, at the Society for Maternal-Fetal Medicine's 33rd annual meeting, The Pregnancy Meeting , researchers will report findings that suggest that 17P, a form of progesterone, is not effective in preventing preterm birth among women with twin pregnancies – and may possibly be harmful. While 17P (17 alpha-hydroxyprogesterone caproate) has been shown to prevent premature delivery among...

2012-07-02 02:24:47

ST. LOUIS, July 2, 2012 /PRNewswire/ -- K-V Pharmaceutical Company (the "Company") (NYSE: KV.A/KV.B) today addressed the additional guidance provided by the U.S. Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena®). FDA provides further guidance to healthcare providers and pregnant women at high risk for recurrent...

2012-06-18 06:30:42

FDA Study Affirms no Major Safety Issues with Compounded 17-P HOUSTON, June 18, 2012 /PRNewswire-USNewswire/ -- Late on Friday, the Food & Drug Administration (FDA) distributed a press release summarizing the findings of a multi-month study of compounded 17-P hydroxyprogesterone preparations, a medication to help prevent pre-term labor. (Logo: http://photos.prnewswire.com/prnh/20111111/DC05358LOGO) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm It is...

2012-06-18 02:28:26

ST. LOUIS, June 18, 2012 /PRNewswire/ -- K-V Pharmaceutical Company ("the Company") (NYSE: KV.A/KV.B) announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth. Prior statements by both agencies had been cited by some payers as the basis for denying patients' access to...

2012-03-28 10:23:08

VIRGINIA BEACH, Va., March 28, 2012 /PRNewswire/ -- Amerigroup Corporation (NYSE: AGP) announced its successful efforts at preventing premature births - as well its commitment to protecting access to affordable drug therapies for at-risk mothers - at the annual Norfolk/Virginia Beach March of Dimes kick-off breakfast for the March for Babies. To view the multimedia assets associated with this release, please click...

2012-02-09 13:15:09

In a study to be presented today at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting , in Dallas, Texas, researchers will report findings that indicate that duration of stay in the United States is associated with increased risk of preterm birth for Hispanic women. "It is uncertain how important environmental factors are in predisposition to preterm birth," said Radek Bukowski, MD, PhD, with the University of Texas Medical Branch, Department of Obstetrics and...

2012-02-09 13:14:15

In a study to be presented today at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting , in Dallas, Texas, researchers will report findings that indicate that prescription medications may affect the body's ability to metabolize 17-alpha-hydroxyprogesterone caproate (17-OHPC), the only FDA approved medication for the prevention of recurrent preterm birth. While 17-OHPC is routinely prescribed, much is still unknown about how it works. Studies have shown a large...

2012-01-20 15:40:00

LIVINGSTON and PARSIPPANY, N.J., Jan. 20, 2012 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI), today confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members...