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

GFA Production (Xiamen) Co., Ltd

Easy Care First Aid® Burn Cream and First Aid Kits
In immunocompromised patients, the topical use of the contaminated Easy Care® AfterBurn® Cream 0.9g single-use packets could potentially result in severe or life-threatening adverse events such as bacteremia, sepsis, and peritonitis. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance skin infections, but in this population the infections are expected to be less severe and more readily responsive to treatment. To date, GFA Production (Xiamen) Co., Ltd. has not received any reports of adverse events related to this recall. The Easy Care first aid® AfterBurn® Cream 0.9 g single-use packet, is used as an over the counter first-aid treatment for minor burns. The single use packets bear lot number W06I28 and are packaged in boxes of ten or included in the certain First Aid kits named below. The lot number of the single use packet can be found on the back of the packet. The lot number for the First Aid Kit that contains the single use packet can be found on each kit, either on the product hang-tag or on the bottom of the kit. The product was distributed nationwide to retailers from March 4, 2022 through December 12, 2022. Refer to the images below for guidance on where to find the lot code details. If your product does not have a lot code that is listed in the below table then it is not part of this recall and can be used as intended.
First Aid


Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial
Administration of Daptomycin 500 mg/vial, to the population most at risk which are children or patients with renal impairment, there is a reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than the intended dose is used which could lead to serious adverse health consequences. If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. To date, Accord has not received any reports of adverse events related to this recall.
The product is used for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureaus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
Exp: 01/2025
NDC16729-435-05 -LOT#R2200232

Quinapril Tablets USP, 20mg-Quinapril Tablets USP, 40mg

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity
Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.
Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure.
G102929 ,G100533,G100534, G203071

Anagrelide Capsules

December 12, 2020
Anagrelide Capsules
Possible Side Effects: Increases the chance of a blood clot


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.


January 5, 2020
100-count bottles of 750 mg Metformin HCl Extended Release Tablets
Possible Side Effects: Carcinogenic

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