Approved Drugs

Orladeyo (berotralstat) Capsules

Date of Approval: December 3, 2020
Treatment for: Hereditary Angioedema

Klisyri (tirbanibulin) Ointment

Date of Approval: December 14, 2020
Treatment for: Actinic Keratosis

Margenza (margetuximab-cmkb) Injection

Date of Approval: December 16, 2020
Treatment for: Breast Cancer

Riabni (rituximab-arrx) Injection

Date of Approval: December 17, 2020
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis

Orgovyx (relugolix) Tablets

Date of Approval: December 18, 2020
Treatment for: Prostate Cancer

Ebanga (ansuvimab-zykl) Injection

Date of Approval: December 21, 2020
Treatment for: Zaire Ebolavirus Infection

Gemtesa (vibegron) Tablets

Date of Approval: December 23, 2020
Treatment for: Overactive Bladder Syndrome

New Indications and Dosage Forms

Drugs that have gained FDA approval for the treatment of additional
diseases/conditions or new dosage forms/regimens.

Kineret (anakinra) Injection

Approval: December 18, 2020
Now Approved for: Deficiency of IL-1 Receptor Antagonist (DIRA

Xolair (omalizumab) Subcutaneous Injection

Approval: December 1, 2020
Now Approved for: Nasal Polyps

Xeomin (incobotulinumtoxinA) Injection

Approval: December 18, 2020
Now Approved for: Chronic Sialorrhea in Patients Aged 2 Years and Older

Benlysta (belimumab) Injection

Approval: December 16, 2020
Now Approved for: Adult Patients with Active Lupus Nephritis

Iclusig (ponatinib) Tablets

Approval: December 18, 2020
Now Approved for: Adult Patients with Resistant or Intolerant Chronic-Phase CML

Hetlioz (tasimelteon) Capsules

Approval: December 1, 2020
Now Approved for: Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Saxenda (liraglutide) Injection

Approval: December 4, 2020
Now Approved for: Obesity in Adolescents Aged 12-17

Tagrisso (osimertinib) Tablets

Approval: December 20, 2020
Now Approved for: Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer

Ocrevus (ocrelizumab) Injection

Approval: December 14, 2020
Now Approved: Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

Xpovio FDA Approval History

Approval: December 14, 2020
Now Approved for: Patients with Multiple Myeloma After At Least One Prior Therapy

Xpovio (selinexor) Tablets

Approval: December 18, 2020
Now Approved for: Patients with Multiple Myeloma After At Least One Prior Therapy

Gavreto (pralsetinib) Capsules

Approval: December 1, 2020
Now Approved for: RET-Mutant and RET Fusion-Positive Thyroid Cancers

Recalled Drugs

Anagrelide Capsules

December 12, 2020
Anagrelide Capsules
Possible Side Effects: Increases the chance of a blood clot
Thrombocythemia
12/2021
800-332-1088

Paroex

October 27, 2020
GUM Paroex Chlorhexidine Gluconate Oral Rinse
Possible Side Effects: oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.
Gingivitis
N/A
800-332-1088

Glucophage

January 5, 2020
100-count bottles of 750 mg Metformin HCl Extended Release Tablets
Possible Side Effects: Carcinogenic
Diabetes
07/2022
800-332-1088