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Latest ondansetron Stories

Pharma Giant Agrees To Pay $3 Billion In Fines For Improper Practices
2012-07-02 19:08:05

Lawrence LeBlond for redOrbit.com - Your Universe Online Pharmaceutical giant GlaxoSmithKline (GSK) pleaded guilty and has agreed to pay the largest fine in US history over charges that it marketed drugs for unauthorized uses, held back safety data, and cheated the government´s Medicaid program, the US Justice Department (DOJ) announced Monday. GSK was also accused of paying kickbacks to doctors, funding expensive trips and other benefits, to gain their support for their drugs....

2012-07-02 06:24:57

LONDON and PHILADELPHIA, July 2, 2012 /PRNewswire/ -- GlaxoSmithKline plc (GSK) today announced that it has reached an agreement with the US Government, multiple states and the District of Columbia to conclude the Company's most significant ongoing Federal government investigations. The final settlement is a result of negotiations which reached agreement in principle in November 2011. GSK will make payments totalling $3bn which are covered by existing provisions and will be funded through...

2012-05-28 02:20:47

CAMBRIDGE, England, May 28, 2012 /PRNewswire/ -- Acacia Pharma announces positive results from its Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV). The study showed that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate-to-high risk of suffering PONV. Vomiting and especially nausea remain a major problem for patients after surgical operations, despite the...

2012-04-19 02:30:18

BOTHELL, Wash., April 19, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., its license partner in developing an extended release version of the popular drug ondansetron (GlaxoSmithKline's brand name Zofran®), has reported successful results in a pivotal bioequivalence trial and intends to meet with the Food and Drug Administration to discuss an approval pathway. RedHill said its draft final report demonstrates that the trial met its...

2012-04-09 06:24:29

BOTHELL, Wash., April 9, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., which has licensed the exclusive worldwide rights to use SCOLR's patented technology to develop an extended release version of the anti-emetic drug ondansetron (brand name Zofran®), has received positive preliminary results in a pharmacokinetic (PK) study comparing its version of ondansetron with Zofran®. RedHill said that, assuming the final clinical study...

2012-02-27 08:08:00

MAPLE GROVE, Minn., Feb. 27, 2012 /PRNewswire/ -- Nausea and vomiting in pregnancy (NVP) is the most common medical condition in pregnancy, affecting an estimated 70 to 85% of all pregnant women.(1) Yet in a recent national survey of more than 350 nurse practitioners (NPs), only 40% of their patients reported experiencing NVP in the last 12 months, pointing to the need for greater patient and healthcare provider dialogue about the condition. The survey was conducted online in November...

2012-02-14 15:01:00

BOTHELL, Wash., Feb. 14, 2012 /PRNewswire/ -- SCOLR Pharma, Inc. (OTCQB: SCLR) announced today that RedHill Biopharma Ltd., a license partner that had previously obtained the exclusive worldwide rights to use SCOLR's patented technology to develop a new version of ondansetron, will conduct a bioequivalence trial in Canada. Both the US Food and Drug Administration (FDA) and Health Canada have reviewed the protocol for the study and have no objections. RedHill submitted an Investigational...

2011-10-04 08:40:00

POINT RICHMOND, Calif., Oct. 4, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has classified the recent Intermezzo® New Drug Application (NDA) resubmission as a complete Class 1 response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 27, 2011 for the completion of the NDA review. About Transcept Transcept...

2011-09-13 21:23:00

POINT RICHMOND, Calif., Sept. 13, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received notice today from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011 Intermezzo® Complete Response Letter. As previously announced, Transcept plans to meet with the FDA on September 14, 2011 to discuss the regulatory path forward for Intermezzo®,...

2011-07-11 07:33:00

WARREN, N.J., July 11, 2011 /PRNewswire/ -- MonoSol Rx, a specialty pharmaceutical company and the developers of the PharmFilm® technology platform, in collaboration with APR Applied Pharma Research s.a. of Switzerland ("APR"), announced today that its FDA-approved anti-emetic Zuplenz (Ondansetron) oral soluble film is available for licensing to new commercial partners. The Company made the strategic decision to reacquire the commercial rights to Zuplenz from Strativa...