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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
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