FDA New Approvals
The FDA has provided approval of Bronchitol (mannitol) inhalation powder. Bronchitol is the first and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis patients aged 18 years and older.
Learn more about Bronchitol
The FDA approved Inmazeb (atoltivimab/maftivimab/odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in
adult and pediatric patients, including newborns of mothers who have tested
positive for the infection. The treatment consists of three monoclonal
antibodies of similar structure, atoltivimab, maftivimab, and odesivimab, that
bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The three
antibodies help neutralize the Ebola virus by blocking its ability to invade
patients’ and/or enlisting other immune cells to target infected cells and
remove them from the body.
Learn more about Inmazeb
The FDA has approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients. Oxlumo is expected to be available for shipment to healthcare providers in the US by year-end.
Learn more about Oxlumo
The FDA has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. It is currently the only FDA-approved room-temperature stable formulation of fosphenytoin sodium. It is FDA approved for adult and pediatric use in the US to treat generalized tonic-clonic status epilepticus, the prevention and treatment of seizures occurring during neurosurgery and for substitution short-term use in place of oral phenytoin when oral phenytoin administration is not possible.
Learn more about Sesquient
The FDA approved Sutab (sodium sulfate/magnesium sulfate/potassium chloride) tablets. Sutab, a sulfate-based tablet preparation for colonoscopy, gives patients and physicians an alternative to liquid-based colonoscopy preparations.
Learn more about Sutab
The FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients aged 12 years and older and weighing at least 40kg (about 88 lb) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
Learn more about Veklury
The FDA has approved Zokinvy
(lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome and
processing-deficient progeroid laminopathies. Zokinvy blocks the accumulation
of defective, farnesylated proteins which form tight associations with the
nuclear envelope, leading to cellular instability and the process of premature
aging in children and young adults. Zokinvy is indicated in adult and pediatric patients aged
12 months and older with a body surface area of 0.39m2 and above.
Learn more about Zokinvy
FDA First-Time Generic Approvals
The FDA provided approval of Gemmily (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, a therapeutically equivalent generic version of Taytulla. Gemmily is the first generic to Taytulla approved in the US. Commercialization activities for Gemmily will begin immediately.
Learn more about Gemmily
FDA New Rx-to-OTC Switch
The FDA approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012. Sklice will be marketed in the US as a nonprescription drug and will no longer be available as a prescription drug.
Learn more about Sklice
FDA New Indications
The FDA has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the DEA. Wakix received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.
Learn more about Wakix
The FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients age 12 years and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water.
Learn more about Xofluza
Fresenius Kabi Dexmedetomidine HCl Injection
Fresenius Kabi is voluntarily recalling a single lot of dexmedetomidine HCl in 0.9% sodium chloride injection, 200mcg/50mL (4mcg/mL), 50mL fill in a 50mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.
Learn more about the Fresenius Kabi Dexmedetomidine HCl Injection recall
Fusion Health and Vitality Core Essential Nutrients and Immune Boost Sublingual Vitamin
Fusion Health and Vitality is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost labeling was found to contain statements that caused it to become an unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth and might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.
Learn more about the Fusion Health and Vitality Core Essential Nutrients and Immune Boost Sublingual Vitamin recall
Lohxa Chlorhexidine Gluconate Oral Rinse
Lohxa is voluntarily
recalling chlorhexidine gluconate oral rinse USP, 0.12% alcohol-free (NDC:70166-027-15) products bearing an expiration date from January
31, 2021 through March 31, 2021, to the consumer level. This product is sourced
and repackaged from Sunstar Americas Inc. who has stated the product may be
contaminated with the bacteria Burkholderia lata.
Learn more about the Lohxa chlorhexidine gluconate oral rinse recall
Nostrum Metformin HCl ER Tablets, 500mg
Nostrum Laboratories is voluntarily recalling 2 lots of metformin HCl extended-release tablets, USP 500mg to the consumer level. The affected lot numbers are MET100201 and MET100401. The product has been found to contain levels of nitrosamine impurities above the ADI limit of 96ng/day.
Learn more about the Nostrum metformin HCl ER tablets, 500mg recall
Nostrum Metformin HCl ER Tablets, 750mg
Nostrum Laboratories is voluntarily recalling 2 lots of metformin HCl extended-release tablets, USP 750mg to the consumer level. The affected lot numbers are MET200101 and MET200301. The product has been found to contain levels of nitrosamine impurities above the ADI limit of 96ng/day.
Learn more about the Nostrum metformin HCl ER tablets, 750mg recall
Sunstar Americas is voluntarily recalling Paroex chlorhexidine gluconate
oral rinse USP, 0.12% products bearing an expiration date from June 30, 2022 through
September 30, 2022, to the consumer level. This product may be contaminated
with the bacteria Burkholderia
Learn more about the Sunstar Paroex recall
FDA Authorizes Bamlanivimab for Treatment of COVID-19
The FDA issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are aged 12 years and older, weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Learn more about the FDA authorizing bamlanivimab for treatment of COVID-19
FDA Authorizes Baricitinib, in Combination with Remdesivir, for Treatment of COVID-19
The FDA has issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients aged 2 years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Learn more about the FDA authorizing baricitinib, in combination with remdesivir, for treatment of COVID-19
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
The FDA issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (aged 12 years or older weighing at least 40kg with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
Learn more about the FDA authorizing monoclonal antibodies for treatment of COVID-19
FDA Authorizes Olumiant, in Combination with Veklury, for Treatment of COVID-19
The FDA issued an emergency use authorization for baricitinib (Olumiant), in combination with remdesivir (Veklury), for the treatment of suspected or laboratory confirmed COVID-19 in certain hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation ECMO.
Learn more about the FDA authorizing Olumiant, in combination with Veklury, for treatment of COVID-19
FDA’s Do-Not-Use Hand Sanitizer List
The FDA recommends checking its do-not-use hand sanitizer list maintained online. The list is updated regularly as new test results are released. Recent additions include instances of sanitizers containing methanol and subpotent for ethanol. The FDA is warning consumers and healthcare providers that the agency has seen a sharp increase in hand sanitizer products labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. The agency is aware of people ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events, including blindness, hospitalizations, and death. Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects.
Learn more about the FDA’s do-not-use hand sanitizer list
Insulin Pen Packaging and Dispensing
The FDA is clarifying the intent of the November 2019 revisions to labeling for insulin pens, which state that healthcare professionals should dispense the pens to a single patient in the original sealed carton. There is an increased risk of dispensing errors and patients using the wrong product if individual insulin pens are stored or dispensed outside of their carton. Insulin pens dispensed individually outside of their cartons may have contributed to medication errors, including wrong-drug and wrong-dose errors resulting in hyper- or hypoglycemia, missed doses, complaints of possible tampering, and dispensing without the instructions for use.
Learn more about insulin pen packaging and dispensing
NSAIDs in Pregnancy
The FDA announced in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications.
Learn more about NSAIDs in pregnancy