Featured News

A flurry of FDA approvals arrive in December to include Lilly’s Zepbound, the 1st prescription drug to treat obstructive sleep apnea, Gemtesa for men with OAB symptoms on BPH treatment, and Bristol-Myers Squibb’s Opdivo Qvantig as the 1st PD-1 inhibitor cancer immunotherapy injected under the skin instead of IV. Steroid-free Vtama cream is okayed for atopic dermatitis (eczema), Steqeyma is the 7th biosimilar to Stelara, and liraglutide is cleared as the 1st generic referencing the GLP-1 agonist Victoza. Additional December approvals include Alhemo, Imfinzi, Unloxcyt, Bizengri, Nemluvio, Crenessity, Ensacove, Ryonsil, Tryngolza, and Alyftrek.

New Drug Approvals

The following drugs have recently been approved by the FDA.

• Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection

  Date of Approval: December 27, 2024
  Treatment for: Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Gastric Cancer
  Press Release | Approval History

• Alhemo (concizumab-mtci) Injection

  Date of Approval: December 20, 2024
  Treatment for: Hemophilia A with Inhibitors, Hemophilia B with Inhibitors
  Press Release | Approval History

• Alyftrek (deutivacaftor, tezacaftor and vanzacaftor)

  Date of Approval: December 20, 2024
  Treatment for: Cystic Fibrosis
  Press Release | Approval History

• Tryngolza (olezarsen) Injection

  Date of Approval: December 19, 2024
  Treatment for: Familial Chylomicronemia Syndrome
  Press Release | Approval History

• Symvess (acellular tissue engineered vessel-tyod) for Surgical Vascular Implantation

  Date of Approval: December 19, 2024
  Treatment for: Revascularization Procedures
  Press Release | Approval History

• Ryoncil (remestemcel-L-rknd) Cell Suspension for Intravenous Infusion

  Date of Approval: December 18, 2024
  Treatment for: Graft Versus Host Disease
  Press Release | Approval History

• Ensacove (ensartinib) Capsules

  Date of Approval: December 18, 2024
  Treatment for: Non Small Cell Lung Cancer
  Press Release | Approval History

• Steqeyma (ustekinumab-stba) Injection

  Date of Approval: December 17, 2024
  Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
  Press Release | Approval History

• Crenessity (crinecerfont) Capsules and Oral Solution

  Date of Approval: December 13, 2024
  Treatment for: Congenital Adrenal Hyperplasia
  Press Release | Approval History

• Unloxcyt (cosibelimab-ipdl) Injection

  Date of Approval: December 13, 2024
  Treatment for: Squamous Cell Carcinoma
  Press Release | Approval History

• Bizengri (zenocutuzumab-zbco) Injection

  Date of Approval: December 4, 2024
  Treatment for: Non Small Cell Lung Cancer, Pancreatic Cancer
  Press Release | Approval History

• Yesintek (ustekinumab-kfce) Injection

  Date of Approval: November 29, 2024
  Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
  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.

• Nemluvio (nemolizumab) for Injection

  Approval: December 13, 2024
  Now Approved for: Atopic Dermatitis
  Press Release | Approval History

• Tevimbra (tislelizumab-jsgr) Injection

  Approval: December 26, 2024
  Now Approved for: First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy
  Press Release | Approval History

• Zepbound (tirzepatide) Injection

  Approval: December 20, 2024
  Now Approved for: Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity
  Press Release | Approval History

• Vtama (tapinarof) Cream

  Approval: December 12, 2024
  Now Approved for: Atopic Dermatitis
  Press Release | Approval History

• Gemtesa (vibegron) Tablets

  Approval: December 18, 2024
  Now Approved for: Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
  Press Release | Approval History

• Imcivree (setmelanotide) Injection

  Approval: December 20, 2024
  Now Approved for: Use in Patients as Young as 2 Years Old
  Press Release | Approval History

• Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules

  Approval: December 20, 2024
  Now Approved for: Additional Non-F508del Trikafta-Responsive Variants
  Press Release | Approval History

• Braftovi (encorafenib) Capsules

  Approval: December 20, 2024
  Now Approved: Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
  Press Release | Approval History

• Imfinzi (durvalumab) Injection

  Approval: December 4, 2024
  Now Approved for: Limited-Stage Small Cell Lung Cancer
  Press Release | Approval History

• Acetadote (acetylcysteine) Injection

  Approval: November 26, 2024
  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.

• Aripiprazole for Extended Release Injectable Suspension
  300 mg/vial and 400 mg/vial
  Approved: December 3, 2024 - Mylan Pharmaceuticals Inc.
  Treatment for: Schizophrenia; Bipolar I Disorder
  Generic for: Abilify Maintena
• Baclofen Oral Solution
  5 mg/5 mL
  Approved: December 6, 2024 - Rubicon Research Private Limited
  Treatment for: Spasticity
  Generic for: Ozobax
• Tromethamine Injection
  18 g/500 mL (3.6 g/100 mL)
  Approved: December 9, 2024 - B. Braun Medical Inc.
  Treatment for: Metabolic Acidosis
  Generic for: Tham
• Iobenguane Sulfate I-123 Injection
  10 mCi/5 mL (2 mCi/mL)
  Approved: December 9, 2024 - BWXT Medical Ltd.
  Use: Diagnostic
  Generic for: AdreView
• Cefixime Tablets
  400 mg
  Approved: December 17, 2024 - FDC Limited
  Treatment for: Bacterial Infections
  Generic for: Suprax Tablets
• Raltegravir Potassium Tablets
  400mg (base)
  Approved: December 19, 2024 - Hetero Labs Limited
  Treatment for: HIV Infection
  Generic for: Isentress
• Liraglutide Subcutaneous Injection
  18 mg/3 mL (6 mg/mL)
  Approved: December 23, 2024 - Hikma Pharmaceuticals USA Inc.
  Treatment for: Type 2 Diabetes
  Generic for: Victoza
• Deutetrabenazine Tablets
  6 mg, 9 mg and 12 mg
  Approved: December 26, 2024 - Aurobindo Pharma Limited
  Treatment for: Huntington's Disease
  Generic for: Austedo

Other Drug News

• Weight-Loss Drugs, Wily Viruses, Abortion Pill Under Attack: The Top Health Stories of 2024
• Data Suggests TNF Inhibitors Help Prevent Serious Complications in Children with Crohn's Disease
• Too Much Acetaminophen Could Harm Seniors' Health
• FDA Approves First Generic of GLP-1 Receptor Agonist Victoza (liraglutide injection) to Lower Blood Sugar in Patients with Type 2 Diabetes
• Could Olumiant Be A New Way to Treat Sjögren’s Disease? Researchers Are Hopeful
• FDA Says Shortage of GLP-1 Tirzepatide (Mounjaro, Zepbound) Is Over
• Early Research Points to Possible New Parkinson's Drug
• U.S. Teen Drug, Alcohol Use Remains at Low Levels
• Study Supports HPV Self-Testing for Cervical Cancer Screening
• Study Supports Tamoxifen for DCIS Early Breast Cancers
• U.S. Adult Obesity Rate Fell in 2023, as Use of GLP-1 Meds Rose
• Who's Most Likely to Get the Mpox Shot in U.S.?
• FDA Revokes EUAs for Four Monoclonal Antibody Products
• Only a Third of U.S. Kids Have Gotten Flu Shots
• Women With Cancer Can Safely Use Rogaine to Curb Hair Loss
• GLP-1 Meds, such as Ozempic or Mounjaro, May Lower Clot Risk in People With Diabetes
• 1 in 6 U.S. Adults With Asthma Can't Afford Meds
• Dolphins Are Testing Positive for Fentanyl
• Everything You Need to Know About Shingles & the Shingles Vaccine
• Novo Nordisk to Lower U.S. List Prices for Tresiba and Fiasp by More Than 70%
• Zepbound Bests Wegovy for Weight Loss in New Trial
• Newer Epilepsy Meds Safe During Pregnancy, Won't Affect Kids' Neurodevelopment

FDA MedWatch Alerts

• Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of Astagraf XL 0.5 mg Because Bottles Shipped to U.S. May Contain Empty Capsules
• Alcon Laboratories Issues Voluntary Nationwide Recall of One Lot of Systane Lubricant Eye Drops Ultra PF Due to Fungal Contamination
• Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors
• Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide
• FDA Adds Boxed Warning to Veozah (fezolinetant) to Highlight the Known Risk of Rare But Serious Liver Injury
• Drug Safety Communication: Ocaliva (obeticholic acid) - Serious Liver Injury Being Observed in Patients without Cirrhosis
• GNMART INC Issues Voluntary Nationwide Recall of Force Forever Due to Undeclared Drug Ingredients Diclofenac and Dexamethasone
• Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine

FDA Consumer Updates

• A Fresh Take on What "Healthy" Means on Food Packages
• Think Before You Ink: Tattoo Safety
• Skip the Antibacterial Soap; Use Plain Soap and Water
• Know Your Treatment Options for COVID-19
• Know When and How to Use Antibiotics, and When to Skip Them

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