FDA Updates

Insulin aspart injection (Fiasp, Novo Nordisk) has been approved for use as a new mealtime insulin option for children with diabetes.

The New Drug Application is seeking approval for ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV in adults.

Olaparib (Lynparza, Merck and AstraZeneca) is approved for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic cancer.

The approvals were granted to generic apixaban applications from Micro Labs Limited and Mylan Pharmaceuticals Inc.

Our most-read FDA approval articles from 2019. 

Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.

Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo and AstraZeneca) is a new treatment option for patients with HER2-positive breast cancer who have progressed after 2 or more prior regimens.

20% subcutaneous immunoglobulin therapy.

Officials with the FDA have approved a new indication and label expansion for icosapent ethyl (Vascepa, Amarin).

Allergan’s positive phase 3 trial results indicate a potential use for the CGRP receptor agonist.

Recent approval under new international Project Orbis.

Ultra-rare, potentially life-threatening genetic disease.

Hemoglobin S Polymerization inhibitor oral treatment.

Approved for patients 18 years of age and older

Antibiotic with a novel penetrative mechanism.

Expected U.S. launch in 2023.

First and currently only biological targeting P-selectin.

MCL is an aggressive form of NHL

Shown to reduce regular RBC transfusions in adults with beta thalassemia.

Fourth filgrastim biosimilar from Sandoz, expected ASAP.

Approved for ages 65 and older.

First and currently only rifabutin-based H. pylori therapy approved.

Delayed-release oral capsules for various forms of the disease.

Commercial launch suspended due to manufacturer liquidity.

New formulation improves safety for patients.

Previously approved for IV infusion.

Fourth indication expansion for the 2009 drug.

Reduces risk for heart failure and cardiovascular disease hospitalizations.