Reports & eBooks

Drug Pipeline & Clinical Update - December 2023

January 9, 2024

Capital Rx


  • Six key new approvals
  • Six new notable expanded indications
  • One biosimilar approval: Avzivi™ for certain types of CRC
  • Four notable generic launches
  • Capital Rx's Updated Drug Recall Report: CLICK HERE to review

Capital Rx's Clinical Team closely monitors the drug landscape to provide our clients with timely information on newly FDA-approved medications, as well as products in the pipeline. Read on to review our December 2023 Monthly Drug Update!

Key New Drug Approvals

Alvaiz™ (eltrombopag) tablet

Approval Date: 11/29/2023 - CLICK HERE for the press release

Indication: Moderate to severe active ulcerative colitis

Cost*: TBD

Key Considerations:

Fabhalta® (iptacopan) capsule

Approval Date: 12/05/2023 - CLICK HERE for the press release

Indication: Paroxysmal nocturnal hemoglobinuria

Cost*: $550,000 annually (WAC)

Key Considerations:

Iwilfin™ (eflornithine) tablet

Approval Date: 12/13/2023 - CLICK HERE for the press release

Indication: Pediatric Neuroblastoma

Cost*: $262,800 annually (WAC)

Key Considerations:

Zoryve® (roflumilast) 0.3% foam

Approval Date: 12/15/2023 - CLICK HERE for the press release

Indication: Seborrheic dermatitis of the scalp

Cost*: TBD

Key Considerations:

Filsuvez® (birch triterpenes) topical gel

Approval Date: 12/19/2023 - CLICK HERE for the press release

Indication: Epidermolysis bullosa

Cost*: TBD

Key Considerations:

Wainua™ (eplontersen) subcutaneous injection

Approval Date: 12/21/2023 - CLICK HERE for the press release

Indication: Familial amyloid polyneuropathy

Cost*: TBD

Key Considerations:

Notable Expanded Indications

Jaypirca® (pirtobrutinib) tablet – expanded to be used for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor

Bivigam® (immune globulin intravenous, human 10% liquid) intravenous injection – expanded to be used for the treatment of pediatric patients two years of age and older with primary humoral immunodeficiency

Cresemba® (isavuconazonium) capsule – expanded for the treatment of invasive aspergillosis and mucormycosis in pediatric patients as young as 12 months of age

Welireg® (belzutifan) tablet – expanded for the treatment of adults with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a VEGF-TKI

Adbry® (tralokinumab-Idrm) subcutaneous injection – expanded for the treatment of atopic dermatitis in pediatric patients 12 years to 17 years of age

Padcev® (enfortumab vedotin-EJFV) intravenous injection – expanded to be used in combination with pembrolizumab in adults with locally advanced or metastatic urothelial cancer

Biosimilar Approvals

Avzivi® (bevacizumab-tnjn) intravenous infusion

Approval Date: 12/06/2023 - CLICK HERE for the press release

Indication: Certain types of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer

Additional Information:

Generic Launches

ProvayBlue® (methylene blue 50mg/10mL) solution

Condylox® (podofilox 0.5%) gel

Lexette® (halobetasol propionate 0.05%) foam

Risperdal Consta® (risperidone extended release 12.5mg, 25mg, 37.5mg, 50mg) intramuscular injection

Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.


* Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support

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