New Drug Approvals in 2019 and Old Drugs with New Warnings

(January 7, 2020)

In 2019, 48 new prescription drugs were approved that were considered to be "new molecular entities" (NME) or "new therapeutical biological products." This is the second-highest number of novel drugs approved in one year, but less than in 2018, when 58 novel drugs won U.S. FDA approval. Generics availability continued to grow in 2019, with 98 first-time generic drugs approved, which is about the same number as last year.

Many of 2019's new drugs treat rare or complicated diseases or conditions. Ten of them are for different kinds of cancer, six are for genetic diseases (including cystic fibrosis, sickle cell disease, Duchenne, and beta thalassemia) two are for migraine, and two treat skin conditions. One of them, called Jeuveau, is the first neurotoxin specifically approved for a cosmetic purpose (improving the appearance of frown lines), and is chemically similar to Botox.

Two unusual antidepressants were approved in 2019. Zulresso, which treats postpartum depression, requires a 3-day stay at a healthcare facility. This is because the medication is administered by I.V. continuously for 60 hours and has risk of loss of consciousness. Another new antidepressant, Spravato (not an NME but a new drug formulation based on ketamine), is a nasal spray and must be administered at a certified health care facility because it contains esketamine, chemically similar to ketamine used as a pre-surgery drug and also in "club drug" known as "Special K." Read more about Spravato:

Here are the novel drugs approved during 2019 and a brief description of the condition they were approved to treat. The list does not include diagnostic drugs such as special dyes used for conducting medical tests.

Accrufer iron deficiency - anemia
Adakveo sickle cell disease complication
Aklief acne
Balversa advanced bladder cancer
Beovu wet age-related macular degeneration
Brukinsa mantle cell lymphoma
Caplyta schizophrenia
Dayvigo insomnia
Enhertu metastatic breast cancer
Evenity osteoporosis if high risk of fracture
Fetroja severe urinary tract infection
Givlaari hepatic porphyria (blood disorder)
Ibsrela irritable bowel syndrome with constipation
Inrebic high-risk primary or secondary myelofibrosis
Jeuveau cosmetic appearance of facial lines
Mayzent relapsing multiple sclerosis
Nourianz Parkinson's disease experiencing off episodes
Nubeqa prostate cancer
Oxbryta sickle cell disease
Padcev non-responsive bladder cancer
Piqray breast cancer
Polivy large B-cell lymphoma
pretomanid treatment-resistant tuberculosis
Reblozyl anemia associated with beta thalassemia
Recarbrio very complicated UTI
Reyvow acute migraine
Rinvoq moderate to severe rheumatoid arthritis
Rozlytrek metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
Skyrizi plaque psoriasis
Sunosi excessive sleepiness
Trikafta cystic fibrosis
Turalio tenosynovial giant cell tumor
Ubrelvy acute migraine
Vyleesi hyposexual desire disorder in women
Vyndaqel heart disease caused by ATTR-CM
Vyondys 53 Duchenne muscular dystrophy
Wakix Excessive daytime sleepiness
Zulresso postpartum depression

Learn more about the newly approved drugs listed above and view select press releases at the FDA:

Drug Safety Warnings and Labeling Changes in 2019

During 2019, there was a surge in the number of safety-related additions or modifications made to drug labels, including 200 "black box" (the most serious) warnings and more than 700 other safety-related warnings or contraindications. In 2016, 2017, and 2018 there were 144 black box warnings for all three years combined, according to the U.S. FDA Drug Safety Labeling database. Only a handful of the 986 label changes in 2019 were publicized through FDA press releases.

FDA Drug Labeling Changes 2016-2019 -
The AskaPatient database will be updated in the next few weeks to include links to all of the safety labeling changes for 2016 -2019.
Here are the most important drug safety communications issued in 2019, with links to FDA press releases:

Valsartan, Losartan, Irbesartan (angiotensin-ii-receptor-blockers)
All year (beginning in 2018): Recalls of this common blood pressure medication have been ongoing due to contamination with NDMA.  

Ranitidine  (Zantac brand name)
Beginning in September 2019: Recalls of this popular h-2 blocker for acid reflux due to contamination with NDMA. Includes brand name and generics.

Gabapentin (Neurontin, Gralise, Horizant) and Pregabalin (Lyrica)
12/19/2019: These seizure and pain medications can cause serious breathing problems.
FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)  

Ibrance, Kisquali, Verzenio
9/13/2019: These breast cancer drugs can cause severe lung inflammation.
FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer  

Mavret, Zepatier, Vovesi
8/28/2019: These hepatitis C medicines can cause serious liver injury.
FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease  

Xeljanz, Xeljanz XR (tocfacitinib)
7/26/2019: These ulcerative colitis and RA drugs can increase risk of blood clots and death.
FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)  

Lunesta (eszopiclone), Sonata (zaleplon), Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)
4/30/2019: A new Boxed Warning was added for these insomnia drugs because of the risk of serious injuries caused by sleepwalking.  

Prescription Opioids (such as Oxycodone, Norco, etc.)
List of Narcotic Pain Relievers
4/9/2019: FDA issues label change warning that sudden discontinuation of opioid pain medications can cause harm and prescribers should use gradual, individualized tapering.
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Uloric (febuxostat)
2/21/2019: A new Boxed Warning is added for this gout drug that it has an increased risk of death (heart-related and other) compared with another gout medicine, allopurinol.
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)