Featured News

In August, the FDA cleared the 2024-2025 COVID-19 mRNA Vaccines from Pfizer and Moderna, plus Neffy is the first needle-free epinephrine for serious allergic reactions. Gilead’s Livdelzi gained accelerated approval for primary biliary cholangitis and Galderma’s Nemluvio improved itching and sleep quality in prurigo nodularis. Rybrevant + Lazcluze and Imfinzi have new uses in lung cancer and other approvals include: Zurnai for opioid overdose, Tecelra for synovial sarcoma, Crexont for Parkinson disease and the biosimilar Enzeevu.

New Drug Approvals

The following drugs have recently been approved by the FDA.

• Pavblu (aflibercept-ayyh) Injection

  Date of Approval: August 23, 2024
  Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
  Press Release | Approval History

• Lazcluze (lazertinib) Tablets

  Date of Approval: August 20, 2024
  Treatment for: Non Small Cell Lung Cancer
  Press Release | Approval History

• Niktimvo (axatilimab-csfr) Injection

  Date of Approval: August 14, 2024
  Treatment for: Graft-versus-host disease
  Press Release | Approval History

• Livdelzi (seladelpar) Capsules

  Date of Approval: August 14, 2024
  Treatment for: Primary Biliary Cholangitis
  Press Release | Approval History

• Nemluvio (nemolizumab) for Injection

  Date of Approval: August 12, 2024
  Treatment for: Prurigo Nodularis
  Press Release | Approval History

• Neffy (epinephrine) Nasal Spray

  Date of Approval: August 9, 2024
  Treatment for: Anaphylaxis
  Press Release | Approval History

• Enzeevu (aflibercept-abzv) Injection

  Date of Approval: August 9, 2024
  Treatment for: Macular Degeneration
  Press Release | Approval History

• Yorvipath (palopegteriparatide) Injection

  Date of Approval: August 9, 2024
  Treatment for: Hypoparathyroidism
  Press Release | Approval History

• Zurnai (nalmefene hydrochloride) Injection

  Date of Approval: August 7, 2024
  Treatment for: Opioid Overdose
  Press Release | Approval History

• Lymphir (denileukin diftitox-cxdl) for Injection

  Date of Approval: August 7, 2024
  Treatment for: Cutaneous T-cell Lymphoma
  Press Release | Approval History

• Crexont (carbidopa and levodopa) Extended-Release Capsules

  Date of Approval: August 7, 2024
  Treatment for: Parkinson's Disease
  Press Release | Approval History

• Voranigo (vorasidenib) Tablets

  Date of Approval: August 6, 2024
  Treatment for: Malignant Glioma
  Press Release | Approval History

• Tecelra (afamitresgene autoleucel) Suspension for Intravenous Infusion

  Date of Approval: August 1, 2024
  Treatment for: Synovial Sarcoma
  Press Release | Approval History

New Indications and Dosage Forms

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

• Fabhalta (iptacopan) Capsules

  Approval: August 7, 2024
  Now Approved for: Primary IgA Nephropathy
  Press Release | Approval History

• NexoBrid (anacaulase-bcdb) Lyophilized Powder for Topical Gel

  Approval: August 15, 2024
  Now Approved for: Pediatric Patients with Severe Thermal Burns
  Press Release | Approval History

• Furoscix (furosemide) Injection

  Approval: August 9, 2024
  Now Approved for: Chronic Heart Failure Regardless of NYHA Functional Class
  Press Release | Approval History

• Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection

  Approval: August 22, 2024
  Now Approved: 2024-2025 Formula Targeting KP.2 Variant
  Press Release | Approval History

• Comirnaty (COVID-19 Vaccine, mRNA) Injection

  Approval: August 22, 2024
  Now Approved: Omicron KP.2-Adapted 2024-2025 Formula
  Press Release | Approval History

• Jemperli (dostarlimab-gxly) Injection

  Approval: August 1, 2024
  Now Approved for: All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer
  Press Release | Approval History

• Imfinzi (durvalumab) Injection

  Approval: August 15, 2024
  Now Approved for: Resectable Non-Small Cell Lung Cancer Before and After Surgery
  Press Release | Approval History

• ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live)

  Approval: August 29, 2024
  Now Approved for: Prevention of Mpox Disease
  Press Release | Approval History

First-Time Generic Approvals

First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.

• Trametinib Dimethyl Sulfoxide Tablets
  0.5 mg (base) and 2 mg (base)
  Approved: August 6, 2024 - Novugen Pharma (USA) LLC
  Treatment for: Cancer
  Generic for: Mekinist
• Lofexidine Hydrochloride Tablets
  0.18mg (base)
  Approved: August 20, 2024 - Indoco Remedies Ltd.
  Treatment for: Opiate Withdrawal
  Generic for: Lucemyra
• Riluzole Oral Suspension
  50 mg/10 mL
  Approved: August 22, 2024 - Alkem Laboratories Ltd.
  Treatment for: Amyotrophic Lateral Sclerosis
  Generic for: Tiglutik
• Methylnaltrexone Bromide Subcutaneous Solution
  8 mg/0.4 mL and 12 mg/0.6 mL
  Approved: August 26, 2024 - Actavis Pharma, Inc.
  Treatment for: Opioid-Induced Constipation
  Generic for: Relistor
• Amantadine Hydrochloride Extended Release Capsules
  68.5mg (base)
  Approved: August 26, 2024 - Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Parkinson's Disease
  Generic for: Gocovri

Other Drug News

• Everything You Need to Know About Insulin
• Ozempic, Wegovy Have Health Benefits Beyond Weight Loss, Studies Find
• Antibiotic Overuse in Nursing Homes Could Foster 'Superbugs'
• Billions of the World's People Deficient in Essential Micronutrients
• Migraine Drug Ubrelvy May Stop Headaches Before They Start
• Recreational Drug Use Triples Odds for Repeat Heart Crises
• Weight-Loss Drug Zepbound Now in Single-Dose Vials at Half the Price
• FDA Clears First Automated Device to Deliver Insulin to People With Type 2 Diabetes
• An Alzheimer's Drug May Also Slow Lewy Body Dementia
• Wegovy Helps Patients With Heart Failure Avoid Heart Attack, Stroke
• Improper Inhaler Use by People With COPD Is Common, Worsening Disease
• Government Report Links Excessive Fluoride in Water to Lowered IQs in Kids
• Naloxone Might Help Revive People After Opioid-Linked Cardiac Arrest
• Mounjaro, Zepbound Cut Odds for Diabetes by 94% in At-Risk People, Study Finds
• Many Cases of Iron Deficiency Go Too Long Without Proper Treatment
• New Deals Will Cut Medicare Costs for Expensive Drugs
• Chemicals in Makeup, Sunscreen May Raise Odds for Dangerous Pregnancy Complication
• FDA Says No to MDMA as Therapy for PTSD
• How Common Drugs, Lotions Can Worsen Sunlight's Harm to Your Skin
• Many Doctors Underestimate the Pain of IUD Insertion for Women. The CDC Wants to Change That
• Painkiller Misuse Common Among People Battling Chronic Pain

FDA MedWatch Alerts

• Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil
• Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
• B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
• FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed for Alertness and Energy Boosting
• Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels

FDA Consumer Updates

• Medicines for Your Pet: What’s the Difference Between FDA-Approved and Pharmacy-Compounded Animal Drugs?
• Spilling the Beans: How Much Caffeine is Too Much?
• Eating Too Much Salt? Ways to Cut Back...Gradually
• Skip the Antibacterial Soap; Use Plain Soap and Water
• It’s a Good Time to Get Your Flu Vaccine

This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party websites.

The Editorial Team,
Drugs.com