Top FDA Drug Approvals from 2019

Over the past year, the FDA has approved a wide range of new drugs and biological products, including novel treatments and expanded indications for a variety of disease states.

Here are some of our top-read FDA approval articles from 2019:

1. Halobetasol propionate and tazarotene (Duobrii, Ortho Dermatologics)

Ortho Dermatologics, a division of Bausch Health Companies, earned FDA approval of Duobrii (halobetasol propionate and tazarotene) in April 2019, the first lotion indicated for adults with plaque psoriasis that contains this combination of active ingredients.

2. Talicia (RedHill Biopharma)

In November 2019, the FDA approved Talicia (RedHill Biopharma), a triple combination therapy comprised of omeprazole magnesium, amoxicillin, and rifabutin for the treatment of Helicobacter pylori (H. pylori) infections in adults.

3. Trifarotene (Aklief)

The FDA has approved Trifarotene (Aklief) topical retinoid 0.005% in October for the treatment of acne vulgaris in patients 9 years of age and older. It is the first retinoid treatment to be approved by the FDA in over 20 years.

4. Siponimod (Mayzent, Novartis)

Novartis’ siponimod (Mayzent) gained FDA approval last March, making it the first treatment to be approved to treat secondary progressive multiple sclerosis (MS) in 15 years.

5. Diroximel fumarate (Vumerity, Biogen and Alkermes)

The FDA approved diroximel fumarate (Vumerity, Biogen and Alkermes) delayed-release oral capsules in October for the treatment of clinically isolated MS, relapsing-remitting disease, and active secondary progressive disease, in adults.

6. Fast-acting insulin aspart injection (Fiasp, Novo Nordisk)

Novo Nordisk’s fast-acting insulin aspart injection was approved in October for use in insulin infusion pumps for adults with type 1 or type 2 diabetes.

7. Quadrivalent influenza vaccine (Fluzone High-Dose, Sanofi)

The FDA recently approved Sanofi’s supplemental Biologics License Application for a Fluzone high-dose quadrivalent influenza vaccine for the prevention of influenza disease caused by Influenza A subtype viruses and type B viruses in adults 65 years of age and older.

8. Solriamfetol (Sunosi, Jazz Pharmaceuticals)

Solriamfetol (Sunosi), which was approved in March, is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults.

9. Dupilumab (Dupixent, Sanofi and Regeneron)

Dupilumab was approved in June as the first treatment for chronic rhinosinusitis with nasal polyps.

10. Baloxavir marboxil (Xofluza, Genentech)

The FDA approved a supplemental new drug application for baloxavir marboxil in October for patients who are at high risk of developing complications from the flu.