Navigation Links
Arbor Pharmaceuticals Announces FDA Approval of First NDA
Date:5/13/2013

span itemprop="name">Laurence Downey , VP of Medical & Scientific Affairs added, "Approval of our first NDA is an important milestone in the evolution of Arbor Pharmaceuticals. This is the first of what we hope will be multiple NDA approvals over the next several years. I would like to thank and congratulate our team that worked on the Nymalize NDA."

Arbor Pharmaceuticals will launch Nymalize in the next few months. 

About Nymalize
Nymalize (nimodipine) oral solution is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with SAH from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).

Important Safety Information About Nymalize
Blood pressure should be carefully monitored during treatment with Nymalize (nimodipine) oral solution. Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, alpha-adrenergic blockers, PDE5 inhibitors, and alpha-methyldopa.

Patients with cirrhosis are at a higher risk of adverse reactions and should be monitored closely and administered a lower dose.

Concomitant use of strong inhibitors of CYP3A4 with nimodipine should generally be avoided due to risk of significant hypotension.  These include some macrolide antibiotics (e.g. clarithromycin, telithromycin), some HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (e.g., boceprevir, telaprevir), some azole antimycotics (e.g., ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delaviridine, and nefazadone. 

Concomitant use of strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampin, St. John's'/>"/>

SOURCE Arbor Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Gilead Sciences Supports HarborPaths HIV/AIDS Medication Assistance Pilot Program
2. Kalyspo Awarded Best of Ann Arbor SPARK Boot Camp
3. Developmental Disabilities Software announces Safe Harbor Self-Certification Compliance
4. Thom Rowland Joins Arbor Pharmaceuticals as Vice President of Commercial Operations
5. HarborPath Creates a Single Portal for Uninsured Individuals to Access HIV/AIDS Medications
6. Arbor Pharmaceuticals partners with the Association of Black Cardiologists to further the campaign of "Saving Hearts of a Diverse America"
7. Optimer Pharmaceuticals Appoints Eric Sirota as Chief Operating Officer
8. Valeant Pharmaceuticals To Webcast 2013 Annual Meeting Of Shareholders
9. Isis Pharmaceuticals to Present at the 2013 UBS Global Healthcare Conference
10. Actinium Pharmaceuticals, Inc. Receives Notice of Patent Allowance for a Key Application
11. Valeant Pharmaceuticals International, Inc. Announces Additional Information Regarding Continuance Proposal
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)...   TRU-D SmartUVC LLC, producers of the ... today that the General Services Administration has awarded the ... This newly formed agreement will allow TRU-D ... purchasers, including Department of Veteran Affairs and Department of ... purchasing solutions for the Ebola effort in ...
(Date:12/22/2014)... Dec. 22, 2014  ConvaTec, a privately-held medical products ... been appointed Interim Chief Executive Officer of the company, ... Ken Berger .  "The Board of Directors of ... ConvaTec over the past three years," said Magnus ... "We are confident that the company is well positioned ...
(Date:12/22/2014)... , Dec. 22, 2014 Swedish Orphan ... today announced that the Committee for Medicinal Products for ... has adopted a positive opinion for the use of ... men with Peyronie,s disease with a palpable plaque and ... start of therapy. The use of Xiapex ...
Breaking Medicine Technology:TRU-D SmartUVC LLC Awarded General Services Administration Contract to Expand Government Customer Base 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 3Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 4Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 5Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 6
(Date:12/24/2014)... 24, 2014 The 2014 Market ... professional and in-depth research report on COC industry. ... basic information, including its definition, classification, application, industry ... etc. This report also presents product specification, manufacturing ... separated by regions, technology and applications. Analysis also ...
(Date:12/24/2014)... Plantation, FL (PRWEB) December 24, 2014 ... permanent solution for a tooth replacement. They offer the ... boast several advantages over other forms of tooth replacement. ... not rely on the adjacent teeth for support, and ... many people have been told that they are not ...
(Date:12/24/2014)... Dr. Ronald Receveur, a New Albany ... dental implants in a day, has written a ... teeth-whitening treatments. , In his blog published Dec. ... writes that overusing teeth-whitening treatments can lead to tooth ... , “Because teeth-whitening treatments are available in ...
(Date:12/24/2014)... Dec. 23, 2014 (HealthDay News) -- Longer and colder body ... who have brain damage from a lack of oxygen, a ... in newborns with this condition -- called hypoxic ischemic encephalopathy ... 33.5 degrees Celsius (92.3 Fahrenheit) for 72 hours, experts say. ... the brains of animals, so this study examined if the ...
(Date:12/22/2014)... (PRWEB) December 22, 2014 B. E. ... to healthcare providers, has been retained to lead a ... Tri-City Medical Center in Oceanside, Calif. The top ... B. E. Smith has recently placed more than 900 ... is a community owned, 397-bed, Gold Seal-approved, full-service acute-care ...
Breaking Medicine News(10 mins):Health News:COC/ Cyclic Olefin Copolymer Market: Global 2015-2020 Forecasts & Research Report Now at DeepResearchReports.com 2Health News:COC/ Cyclic Olefin Copolymer Market: Global 2015-2020 Forecasts & Research Report Now at DeepResearchReports.com 3Health News:Innovative Dental Implant Procedure to Gain Momentum in the New Year 2Health News:New Albany Dentist Weighs In On New Trend of Overbleaching Teeth 2Health News:New Albany Dentist Weighs In On New Trend of Overbleaching Teeth 3Health News:Greater Cooling of Oxygen-Deprived Infants Fails to Improve Survival 2Health News:Tri-City Medical Center Retains B. E. Smith to Recruit New Chief Compliance Officer 2Health News:Tri-City Medical Center Retains B. E. Smith to Recruit New Chief Compliance Officer 3
... new study published in the journal Ultrasound in Obstetrics ... infant survival rate in severe cases of congenital diaphragmatic hernia ... a severe malformation (hole) of the diaphragm and is a ... an incomplete development of the lungs. Researchers led by ...
... FOR DEC. 14, 2011] The two main ways to ... antiviral drugs. A team of investigators has found that ... complement these approaches and reduce mortality among patients hospitalized ... Journal of Infectious Diseases and are now available ...
... Dec. 13 (HealthDay News) -- An older woman,s sleep/wake cycle ... developing dementia, a new study suggests. It found that ... that sometimes precedes dementia) was higher in older women with ... more active later in the day, compared to those who ...
... fluid bathing the brain are linked to poor recovery ... University School of Medicine in St. Louis and the ... "We are particularly interested in finding ways to ... David L. Brody, MD, PhD, assistant professor of neurology ...
... 13, 2011 The American Cancer Society has revised ... consistency, and rigor in creating guidance about cancer ... from the Institutes of Medicine (IOM) by creating ... commissioning systematic evidence reviews, and clearly articulating the ...
... The U.S. Department of Justice filed a proposed consent ... requirements for three major tobacco companies to make internal ... the companies violated the Racketeer Influenced and Corrupt Organizations ... Tobacco Documents Library (LTDL). The order, once approved ...
Cached Medicine News:Health News:Statins may reduce mortality in patients hospitalized with influenza 2Health News:'Body Clock' Might Affect Women's Dementia Risk 2Health News:High levels of tau protein linked to poor recovery after brain injury 2Health News:High levels of tau protein linked to poor recovery after brain injury 3Health News:American Cancer Society revises cancer screening guideline process 2Health News:UCSF to receive tobacco papers, funding to improve public access to the documents 2
The TCM400 is the first and only portable instrument to provide up to six simultaneous measurements of transcutaneous oxygen tension (tcpO2)...
Two separate sensors provide continuous measurement of tcpO2/tcpCO2 and SpO2....
... the only online source of nationally accredited ... care nurses and other healthcare professionals., ,Radiometers ... you can take them at your convenience. ... is issued upon course completion. The curriculum ...
... components that comprise the SmartPill GI ... comprise the SmartPill GI Monitoring System: ... Receiver software and SmartPill MotiliGI software. ... indispensable parts of the SmartPill GI ...
Medicine Products: