By: Neelam Sharma MS, Lavanya Kundurthy BE and Hemant N. Joshi, Ph.D., MBA, Tara Innovations LLC
This quarterly review on New Drug Applications contains data for applications approved during the third quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 48 applications were approved by the FDA during these three months.
The NDAs approved during the third quarter of 2025 have been divided into 13 different dosage forms. Following are the percentages of those dosage forms – injection (37.5%), Oral Tablets (22.9%), Oral Capsules, Oral Suspension and Ophthalmic products 6.3% each, Oral granules 4.2%, and Sublingual tablets, Oral powder, oral solution, Otic solution, Topical, Nasal spray and for Oral solution 2.1% each. Following are the submission classifications: BLA (36.7%), Type 1 (new molecular entity, 26.5%), Type 3 (new dosage form, 28.6%), Type 4 (new combination), Type 5 (new formulation or manufacturer, 16.3%), Type 7 (drug already marketed without approved NDA, 2.0%), and Type 9 (new indication submitted as distinct NDA, consolidated with original NDA upon approval, 2.0%).
Doptelet and Doptelet Sprinkle (avatrombopag) offer a fast and durable platelet response and are the only TPO-RAs (Thrombopoietin Receptor Agonists) without dietary restrictions and liver monitoring. These are indicated for patients aged >1 and <6 years. Doptelet tablets are indicated for patients aged over 6 years. Doptelet tablets and sprinkles are not to be substituted on a mg-to-mg basis. TPO-RA bind to TPO receptors to help increase platelet production in persistent or chronic immune thrombocytopenia (ITP).
Wayrilz (Rilzabrutinib) is another new drug approved to treat adults with persistent or chronic ITP who have received a prior treatment that did not work well enough. Wayrilz may cause serious side-effects – serious infections and liver problems including drug-induced liver injury.
Biocon Biologics made an impressive performance getting three drugs approved in one quarter – Kirsty (Insulin aspart – xjhz), Aukelso (Denosumab-kyqq – biosimilar to Xgeva) and Bosaya (Denosumab-Kyqq – biosimilar to Prolia). Similarly, Shanghai Henlius Biotech received two BLAs approved in this quarter – Bildyos (Denosumab- nxxp, biosimilar to Prolia) and Bilprevda (Denosumab-nxxp – biosimilar to Xgeva). Hikma Pharma received two BLAs approved in this quarter - Enoby (Denosumab – qbde – biosimilar to Prolia) and Xtrenbo (Denosumab-qbde – biosimilar to Xgeva).
Inluriyo (Imlunestrant) is a new prescription medicine used to treat adults with advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic) whose disease was previously treated with endocrine therapy. The breast cancer must be ER+ (estrogen receptor positive), HER2– (human epidermal growth factor receptor 2 negative), and ESR1-mutated (Estrogen receptor 1).
Palsonify (paltusotine) is a new once-daily oral tablet (equivalent to 20 mg or 30 mg base) approved to treat adults with acromegaly who either didn’t get much help from surgery or can’t have surgery for certain reasons. Acromegaly is a rare condition caused by too much growth hormone production usually due to a tumor in the pituitary gland.
|
Approval
Date
|
Drug name
|
Active
ingredients
|
Submission class. *
|
Company
|
Dosage form
|
Comments
|
|---|
|
07/02/2025
|
Zegfrovy
|
Sunvozertinib
|
Type 1
|
Dizal Jiangsu
|
Tablet; oral
|
Metastatic NSCLC targeting EGFR exon 20 insertion mutations
|
|
07/02/2025
|
Lynozyfic
|
Linvoseltamab-
gcpt
|
BLA
|
Regeneron
|
Solution;
injection
|
Treatment of patients with relapsed or refractory multiple myeloma (RRMM)
|
|
07/03/2025
|
Bendamustine
hydrochloride
|
Bendamustine
hydrochloride
|
Type5
|
DR Reddy’s
|
Solution;
intravenous
|
Anti-cancer medication used in the treatment of CLL and NHL
|
|
07/03/2025
|
Ekterly
|
Sebetralstat
|
Type1
|
KalVista
|
Tablet; oral
|
Treat symptoms of hereditary angioedema (swelling) attacks
|
|
07/15/2025
|
Kirsty
|
Insulin aspart-xjhz
|
BLA
|
Biocon Biologics
|
Injection;
solution
|
The first and only interchangeable biosimilar rapid-acting Insulin Aspart
|
|
07/16/2025
|
Famotidine
|
Famotidine
|
Type5
|
Sagent
|
Solution;
intravenous
|
Treat ulcers of the stomach and intestines
|
|
07/23/2025
|
Anzupgo
|
Delgocitinib
|
Type1
|
Leo Pharma
|
Cream; topical
|
Steroid free hand cream to treat Chronic Hand Eczema
|
|
07/23/2025
|
Vostally
|
Ramipril
|
Type3
|
Rosemont
Pharma
|
Solution; oral
|
To treat hypertension, reduce risk of cardiovascular events
|
|
07/24/2025
|
Sdamlo
|
Amlodipine
besylate
|
Type3
|
Brillian Pharma
|
For solution; oral
|
For the treatment of hypertension
|
|
07/24/2025
|
Doptelet
sprinkle
|
Avatrombopag
maleate
|
Type3
|
AkaRx inc.
|
Granule; oral
|
An oral chronic ITP medication that helps increase platelet counts
|
|
07/28/2025
|
Sephience
|
Sepiapterin
|
Type1
|
PTC Therapeutics
|
Powder; oral
|
Helps to reduce blood phenylalanine and Phenylketonuria levels
|
|
07/29/2025
|
Vyscoxa
|
Celecoxib
|
Type3
|
Carwin Pharm Assoc.
|
Suspension; oral
|
A nonsteroidal anti-inflammatory drug for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
|
|
07/30/2025
|
Atmeksi
|
Methocarbamol
|
Type 9
|
Rosemont
Pharma
|
Suspension; oral
|
A muscle relaxant to treat acute, painful musculoskeletal conditions
|
|
07/31/2025
|
Vizz
|
Aceclidine
hydrochloride
|
Type1
|
LENZ
Therapeutics
|
Solution/drops;
ophthalmic
|
The first and only aceclidine-based eye drop approved to improve near vision
|
|
07/31/2025
|
Alhemo
|
Concizumab
|
BLA
|
Novo Nordisk
|
Solution;
injection
|
Used to prevent bleeding episodes
(prophylaxis) with hemophilia A or B
|
|
08/01/2025
|
E-z-disk
|
Barium sulfate
|
Type7
|
Bracco
|
Tablet; oral
|
Used in radiography of the esophagus, for detection of esophageal strictures
|
|
08/06/2025
|
Modeyso
|
Dordaviprone
hydrochloride
|
Type 1
|
Chimerix
|
Capsule; oral
|
The first and only treatment for recur-rent H3 K27M-mutant Diffuse Midline Glioma
|
|
08/08/2025
|
Hernexeos
|
Zongertinib
|
Type1
|
Boehringer
Ingelheim
|
Tablet; oral
|
First oral targeted treatment for HER2-
Mutant Advanced Lung Cancer
|
|
08/08/2025
|
Kyxata
|
Carboplatin
|
Type5
|
AVYXA Holdings
|
Solution;
intravenous
|
To treat ovarian carcinoma recurrent after prior chemotherapy
|
|
08/12/2025
|
Brinsupri
|
Brensocatib
|
Type1
|
Insmed Inc.
|
Tablet; oral
|
The first and only FDA-approved treatment proven to reduce bronchiectasis flares
|
|
08/15/2025
|
Cyklx
|
Articaine HCl
|
Type 3 & Type4
|
AM Genomics
|
Solution/drop;
ophthalmic
|
To anesthetize the surface of the eye before eye procedures
|
|
08/15/2025
|
Tonmya
|
Cyclobenzaprine
HCl
|
Type3
|
Tonix
|
Tablet; sublingual
|
It is the first FDA-approved therapy to treat fibromyalgia
|
|
08/21/2025
|
Dawnzera (autoinjector)
|
Donidalorsen
sodium
|
Type1
|
Ionis Pharms Inc.
|
Solution;
subcutaneous
|
First and only RNA-targeted prophylactic treatment for hereditary angioedema
|
|
08/25/2025
|
Camcevietm
|
Leuprolide
mesylate
|
Type5
|
Foresee
Pharma
|
Emulsion;
subcutaneous
|
Effective advanced prostate cancer therapy to lower testosterone
|
|
08/28/2025
|
Lopressor
|
Metoprolol
tartrate
|
Type5
|
XTM Consulting
|
Tablet; oral
|
For the treatment of hypertension, to lower blood pressure
|
|
08/29/2025
|
Otezla
|
Apremilast
|
Type5
|
Amgen Inc.
|
Tablet; oral
|
Oral tablet form
|
|
08/29/2025
|
Otezla xr
|
Apremilast
|
Type 5
|
Amgen Inc.
|
Tablet ER; oral
|
Extended-release oral tablet form
|
|
08/29/2025
|
Escitalopram
|
Escitalopram
oxalate
|
Type3
|
Almatica
|
Capsule; oral
|
A new dosage form approved
|
|
08/29/2025
|
Wayrilz
|
Rilzabrutinib
|
Type1
|
Genzyme
Corp.
|
Tablet; oral
|
For persistent or chronic immune thrombocytopenia (ITP)
|
|
08/29/2025
|
Leqembi
iqlik
|
Lecanemab-irmb
|
BLA
|
Eisai Inc.
|
Injectable;
injection
|
Subcutaneous (weekly autoinjector) maintenance dose for patients with early Alzheimer’s disease
|
|
08/29/2025
|
Bildyos
|
Denosumab-
nxxp
|
BLA
|
Shanghai
Henlius
|
Injectable;
injection
|
A biosimilar to Prolia for treatment of osteoporosis and bone loss
|
|
08/29/2025
|
Bilprevda
|
Denosumab-
nxxp
|
BLA
|
Shanghai
Henlius
|
Injectable;
injection
|
Biosimilar to Xgeva
|
|
09/09/2025
|
Zolymbus
|
Bimatoprost
|
Type3
|
Thea Pharma
|
Gel;
ophthalmic
|
For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
|
|
09/09/2025
|
Inlexzo
|
Gemcitabine
hydrochloride
|
Type3
|
Janssen
Biotech
|
System;
intravesical
|
For adult patients with BCG unresponsive non muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors
|
|
09/10/2025
|
Koselugo
|
Selumetinib
|
Type3
|
AstraZeneca
|
Granule; oral
|
Approval expanded to include children aged 1 year and older (in both capsule and granule formulations)
|
|
09/10/2025
|
Koselugo
|
Selumetinib
sulfate
|
Type3
|
AstraZeneca
|
Capsule; oral
|
Approval expanded to include children aged 1 year and older (in both capsule and granule formulations)
|
|
09/12/2025
|
Enbumyst
|
Bumetanide
|
Type3
|
Corstasis
Therapy
|
Spray; nasal
|
For the treatment of edema associated with congestive heart failure, liver disease and kidney disease (including nephrotic syndrome) in adults
|
|
09/16/2025
|
Subvenite
|
Lamotrigine
|
Type3
|
OWP Pharma
|
Suspension; oral
|
The first and only FDA-approved oral formulation of lamotrigine used to treat epilepsy and bipolar disorder
|
|
09/16/2025
|
Aukelso
|
Denosumab-
kyqq
|
BLA
|
Biocon
Biologics
|
Injectable;
injection
|
Biosimilar to Xgeva
|
|
09/16/2025
|
Bosaya
|
Denosumab-
kyqq
|
BLA
|
Biocon
Biologics
|
Injectable;
injection
|
Biosimilar to Prolia
|
|
09/19/2025
|
Forzinity
|
Elamipretide
hydrochloride
|
Type1
|
Stealth
Biotherapeutics
|
Solution;
subcutaneous
|
First FDA-approved treatment for Barth syndrome
|
|
09/19/2025
|
Keytruda
qlex
|
Pembrolizumab;
berahyaluronidase alfa-pmph
|
BLA
|
Merck Sharp Dohme
|
Injectable;
injection
|
Subcutaneous injection for solid tumor indications as the intravenous version of KEYTRUDA
|
|
09/24/2025
|
Bondlido
|
Lidocaine
|
Type5
|
MedRx USA Inc.
|
Topical system
|
For relief of pain associated with post herpetic neuralgia in adults
|
|
09/25/2025
|
Inluriyo
|
Imlunestrant
|
Type1
|
Eli Lilly and Co.
|
Tablet; oral
|
For adults with estrogen receptor positive (ER+), HER2 negative, ESR1 mutated advanced or metastatic breast cancer
|
|
09/25/2025
|
Palsonify
|
Paltusotine
|
Type 1
|
Crinetics Pharma Inc.
|
Tablet; oral
|
For the treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option
|
|
09/26/2025
|
Clotic
|
Clotrimazole
|
Type 3
|
Laboratorios Salvat, S.A.
|
Solution; otic
|
For the treatment of fungal otitis externa (otomycosis) caused by Aspergillus and Candida species
|
|
09/26/2025
|
Enoby
|
Denosumab-
qbde
|
BLA
|
Hikma
Pharmaceuticals
USA Inc.
|
Solution;
injection
|
Biosimilar to Prolia, for treatment of osteoporosis in certain high risk populations
|
|
09/26/2025
|
Xtrenbo
|
Denosumab-
qbde
|
BLA
|
Hikma
Pharmaceuticals
USA Inc.
|
Solution;
injection
|
Biosimilar to Xgeva for preventing skeletal-related events in patients with certain cancers
|
|
BLA: Biologics License agreement, Type 1: New Molecular entity, Type 3: New dosage form, Type 4 – New combination, Type 5 – New formulation or manufacturer, Type 7 - Drug Already Marketed without Approved NDA, Type 9 - new indication submitted as distinct NDA, consolidated with original NDA after approval.
|