Original New Drug Application Approvals by US FDA (16-30 September 2025) | Multidisciplinary

New drug applications approved by US FDA as of 16-30 September 2025 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.

SUBVENITE

Active Ingredient(s): Lamotrigine
Strength: 10MG/ML
Dosage Form(s) / Route(s): Suspension;oral
Company: Owp Pharms
Approval Date: 16 September 2025
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
- partial-onset seizures
- primary generalized tonic-clonic (PGTC) seizures
- generalized seizures of Lennox-Gastaut syndrome.
Epilepsy—monotherapy in patients aged 16 years and older:
- Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.
Bipolar disorder:
- Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
Limitations of Use:
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of SUBVENITE in the acute treatment of mood episodes has not been established.
Approved Label: 16 September 2025 (PDF)

AUKELSO

Active Ingredient(s): Denosumab-kyqq
Strength: 60MG/ML
Dosage Form(s) / Route(s): Injectable;injection
Company: Biocon Biologics Inc
Approval Date: 16 September 2025
Submission Classification: NA
Indication(s): Indicated for for treatment:

of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Approved Label: 16 September 2025 (PDF)

BOSAYA

Active Ingredient(s): Denosumab-kyqq
Strength: 60MG/ML
Dosage Form(s) / Route(s): Injectable;injection
Company: Biocon Biologics Inc
Approval Date: 16 September 2025
Submission Classification: NA
Indication(s): Indicated for for treatment:

of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

Approved Label: 16 September 2025 (PDF)

FORZINITY

Active Ingredient(s): Elamipretide Hydrochloride
Strength: EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)
Dosage Form(s) / Route(s): Solution;subcutaneous
Company: Stealth Biotheraps
Approval Date: 19 September 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Approved Label: 19 September 2025 (PDF)

KEYTRUDA QLEX

Active Ingredient(s): Pembrolizumab;berahyaluronidase Alfa-pmph
Strength: 395MG/4800UNITS(2.4ML); 790MG/9600UNITS(4.8ML)
Dosage Form(s) / Route(s): Injectable;injection
Company: Merck Sharp Dohme
Approval Date: 19 September 2025
Submission Classification: NA
Indication(s): Indicated:
Melanoma
- for the treatment of adult patients with unresectable or metastatic melanoma.
- for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer (NSCLC)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of adult patients with metastatic squamous NSCLC.
as a single agent for the first-line treatment of adult patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
metastatic.

as a single agent for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA QLEX.
for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma (MPM)

in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.

Head and Neck Squamous Cell Cancer (HNSCC)

in combination with platinum and FU for the first-line treatment of adult patients with metastatic or with unresectable, recurrent HNSCC.
as a single agent for the first-line treatment of adult patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
as a single agent for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Urothelial Cancer

in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
as a single agent for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who

are not eligible for any platinum-containing chemotherapy, or
who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinumcontaining chemotherapy.

as a single agent for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instabilityhigh (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC)

for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

in combination with trastuzumab, fluoropyrimidine-and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
n combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Esophageal Cancer

for the treatment of adult patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum-and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1), or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

in combination with chemoradiotherapy, for the treatment of adult patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
in combination with chemotherapy, with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDAapproved test.
as a single agent for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma (HCC)

for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer (BTC)

in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer.

Merkel Cell Carcinoma (MCC)

for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma.

Renal Cell Carcinoma (RCC)

in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions..

Endometrial Carcinoma

in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High (TMB-H) Cancer

for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burdenhigh (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Limitations of Use: The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma (cSCC)

for the treatment of adult patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer (TNBC)

for the treatment of adult patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.

Approved Label: 19 September 2025 (PDF)

BONDLIDO

Active Ingredient(s): Lidocaine
Strength: 10%
Dosage Form(s) / Route(s): System;topical
Company: Medrx Usa
Approval Date: 24 September 2025
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated in adults for relief of pain associated with post-herpetic neuralgia (PHN).
Approved Label: 24 September 2025 (PDF)

INLURIYO

Active Ingredient(s): Imlunestrant Tosylate
Strength: EQ 200MG BASE
Dosage Form(s) / Route(s): Tablet;oral
Company: Eli Lilly And Co
Approval Date: 25 September 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for:
- treatment of adults with ER-positive, HER2-negative, ESR1mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Approved Label: 25 September 2025 (PDF)

PALSONIFY

Active Ingredient(s): Paltusotine Hydrochloride
Strength: EQ 20MG BASE; EQ 30MG BASE
Dosage Form(s) / Route(s): Tablet;oral
Company: Crinetics
Approval Date: 25 September 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Approved Label: 25 September 2025 (PDF)

CLOTIC

Active Ingredient(s): Clotrimazole
Strength: 1%
Dosage Form(s) / Route(s): Solution/drops;otic
Company: Lab Salvat
Approval Date: 26 September 2025
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older.
Limitations of Use
CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes.
Approved Label: 26 September 2025 (PDF)

ENOBY

Active Ingredient(s): Denosumab-qbde
Strength: 60MG/ML
Dosage Form(s) / Route(s): Solution;injection
Company: Hikma Pharmaceuticals Usa Inc
Approval Date: 26 September 2025
Submission Classification: NA
Indication(s): Indicated for treatment:
- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Approved Label: 26 September 2025 (PDF)

XTRENBO

Active Ingredient(s): Denosumab-qbde
Strength: 120MG/1.7ML(70MG/ML)
Dosage Form(s) / Route(s): Solution;injection
Company: Hikma Pharmaceuticals Usa Inc
Approval Date: 26 September 2025
Submission Classification: NA
Indication(s): Indicated for treatment:
- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Approved Label: 26 September 2025 (PDF)

RHAPSIDO

Active Ingredient(s): Remibrutinib
Strength: 25MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Novartis
Approval Date: 30 September 2025
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
Approved Label: 30 September 2025 (PDF)