Brian Park, PharmD

Brian Park, PharmD

Drug Information Specialist https://www.empr.com
Brian Park, PharmD, is a Drug Information Specialist at MPR. A graduate of the Ernest Mario School of Pharmacy, Rutgers University, Brian worked as a pharmacy manager at Stop & Shop Pharmacy for 8 years. He is a certified diabetes care pharmacist.

All articles by Brian Park, PharmD

BLA Submitted for Gene Therapy to Treat Hemophilia A

BioMarin has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for valoctocogene roxaparvovec (BMN 270) for the treatment of hemophilia A in adults. This is the first marketing application submission for a gene therapy product for any type of hemophilia. Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy…

FDA Issues Complete Response Letter for Long-Acting Injectable HIV Regimen

The Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the 2-drug long-acting injectable regimen of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) for the treatment of HIV-1 infection in adults.  In the CRL, the FDA could not approve the NDA for reasons pertaining to Chemistry, Manufacturing…

Zilretta Labeling Updated to Include Information Pertaining to Repeat Administration

The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) to update the product labeling for Zilretta (triamcinolone acetonide extended-release injectable suspension; Flexion Therapeutics) for the management of osteoarthritis (OA) knee pain. Zilretta combines triamcinolone acetonide, a short-acting corticosteroid, with a poly lactic-co-glycolic acid (PLGA) matrix to be administered by intra-articular injection.…

Ubrelvy Approved for Acute Treatment of Migraine

The Food and Drug Administration (FDA) has approved Ubrelvy (ubrogepant tablets; Allergan), the first oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults. The approval was supported by two pivotal phase 3, randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II) that evaluated the efficacy,…

First Generics of Eliquis Receive Approval

The Food and Drug Administration (FDA) has approved the first generics of Eliquis (apixaban; Bristol-Myers Squibb and Pfizer) tablets. Apixaban, a factor Xa inhibitor, is indicated: To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism…

FDA Approves Caplyta for Schizophrenia

The Food and Drug Administration (FDA) has approved Caplyta (lumateperone; Intra-Cellular Therapies), an atypical antipsychotic, for the treatment of schizophrenia in adult patients. The approval was based on results from 2 double-blind, placebo-controlled trials (Study 1 [N=335] and Study 2 [N=450]) that evaluated the efficacy of Caplyta in patients with schizophrenia for 28 days. Findings…