Original New Drug Application Approvals by US FDA (01-15 December 2023)

New drug applications approved by US FDA as of 01-15 December 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

FABHALTA

• Active Ingredient(s): Iptacopan Hydrochloride
• Strength: 200MG
• Dosage Form(s) / Route(s): Capsule;oral
• Company: Novartis Pharms Corp
• Approval Date: 05 December 2023
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
• Approved Label:  05 December 2023 (PDF)

AVZIVI

• Active Ingredient(s): Bevacizumab-tnjn
• Strength: 100MG/4ML(25MG/ML), 400MG/16ML(25MG/ML)
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Bio-thera Solutions Ltd
• Approval Date: 06 December 2023
• Submission Classification: N/A
• Indication(s): Indicated for the treatment of:
  • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
  • Metastatic colorectal cancer, in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  Limitations of Use: Avzivi is not indicated for adjuvant treatment of colon cancer.
  • Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
  • Recurrent glioblastoma in adults.
  • Metastatic renal cell carcinoma in combination with interferon alfa.
  • Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.
• Approved Label:  06 December 2023 (PDF)

IWILFIN

• Active Ingredient(s): Eflornithine
• Strength: 192MG
• Dosage Form(s) / Route(s): Tablet;oral
• Company: USWM
• Approval Date: 13 December 2023
• Submission Classification: N/A
• Indication(s): Indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
• Approved Label:  13 December 2023 (PDF)

IDOSE TR

• Active Ingredient(s): Travoprost
• Strength: 75MCG
• Dosage Form(s) / Route(s): Implant;ophthalmic
• Company: Glaukos Corp
• Approval Date: 13 December 2023
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
• Approved Label:  13 December 2023 (PDF)

HYDROMORPHONE; HYDROCHLORIDE

• Active Ingredient(s): Hydromorphone;hydrochloride
• Strength: 2MG/ML
• Dosage Form(s) / Route(s): Injectable;injection
• Company: Hikma Pharms
• Approval Date: 14 December 2023
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.
  Limitations of Use:
  Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.1), reserve Hydromorphone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or opioid combination products):
  • Have not been tolerated or are not expected to be tolerated
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia
  Hydromorphone Hydrochloride Injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
• Approved Label:  14 December 2023 (PDF)

ZORYVE

• Active Ingredient(s): Roflumilast
• Strength: 0.3%
• Dosage Form(s) / Route(s): For Solution, Tablet, Delayed Release;oral
• Company: Arcutis Biotherapeutics Inc
• Approval Date: 15 December 2023
• Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
• Indication(s): Indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
• Approved Label:  15 December 2023 (PDF)