Original New Drug Application Approvals by US FDA (16-31 July 2024) | Multidisciplinary

New drug applications approved by US FDA as of 16-31 July 2024 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.

VOQUEZNA

Active Ingredient(s): Vonoprazan Fumarate
Strength: EQ 10MG BASE; EQ 20MG BASE
Dosage Form(s) / Route(s): Tablet;oral
Company: Phathom Pharmaceuticals Inc
Approval Date: 17 July 2024
Submission Classification: NA
Indication(s): Indicated:

for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults.
in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection in adults.
in combination with amoxicillin for the treatment of H. pylori infection in adults.

Approved Label: 17 July 2024 (PDF)

ZITUVIMET XR

Active Ingredient(s): Metformin Hydrochloride; Sitagliptin
Strength: 500MG;50MG, 1GM;50MG, 1GM;100MG
Dosage Form(s) / Route(s): Tablet, Extended Release;oral
Company: Zydus
Approval Date: 18 July 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not for the treatment of type 1 diabetes mellitus.
Has not been studied in patients with a history of pancreatitis.

Approved Label: 18 July 2024 (PDF)

EPYSQLI

Active Ingredient(s): Eculizumab-aagh
Strength: 300 mg/30 mL (10 mg/mL)
Dosage Form(s) / Route(s): Injection;solution
Company: Samsung Bioepis Co Ltd
Approval Date: 19 July 2024
Submission Classification: NA
Indication(s): Indicated for:

The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use:

EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Approved Label: 19 July 2024 (PDF)

OPIPZA

Active Ingredient(s): Aripiprazole
Strength: 2MG; 5MG; 10MG
Dosage Form(s) / Route(s): Film;oral
Company: Xiamen Lp Pharm Co
Approval Date: 22 July 2024
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for:

treatment of schizophrenia in patients ages 13 years and older
adjunctive treatment of major depressive disorder (MDD) in adults
irritability associated with autistic disorder in pediatric patients 6 years and older
treatment of Tourette’s disorder in pediatric patients 6 years and older

Approved Label: 22 July 2024 (PDF)

FEMLYV

Active Ingredient(s): Norethindrone Acetate And Ethinyl Estradiol
Strength: 1MG/0.02MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Millicent Puerto Rico Llc
Approval Date: 22 July 2024
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy.

Limitation of Use:

Approved Label: 22 July 2024 (PDF)

LEQSELVI

Active Ingredient(s): Deuruxolitinib Phosphate
Strength: 8MG
Dosage Form(s) / Route(s): Tablet;oral
Company: Sun Pharm Inds
Approval Date: 25 July 2024
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of adults with severe alopecia areata.

Limitation of Use:

Approved Label: 25 July 2024 (PDF)

ERZOFRI

Active Ingredient(s): Paliperidone Palmitate
Strength: 39MG/0.25ML, 78MG/0.5ML, 117MG/0.75ML, 156MG/ML, 234MG/1.5ML, 351MG/2.25ML
Dosage Form(s) / Route(s): Injectable; Suspension, Extended Release
Company: Luye Innomind Pharma Shijiazhuang Co., Ltd.
Approval Date: 26 July 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for:

Treatment of schizophrenia in adults.
Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

Approved Label: 26 July 2024 (PDF)

POTASSIUM PHOSPHATES IN SODIUM CHLORIDE

Active Ingredient(s): Potassium Phosphates In Sodium Chloride
Strength: 15MMOL/250ML / 22MEQ/250ML
Dosage Form(s) / Route(s): Injectable;intravenous
Company: Amneal Eu Ltd
Approval Date: 26 July 2024
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated.
Approved Label: 26 July 2024 (PDF)

ZUNVEYL

Active Ingredient(s): Benzgalantamine
Strength: 5MG, 10MG, 15MG
Dosage Form(s) / Route(s): Tablet, Delayed Release;oral
Company: Alpha Cognition Inc
Approval Date: 26 July 2024
Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.
Approved Label: 26 July 2024 (PDF)

TEZRULY

Active Ingredient(s): Terazosin Hydrochloride
Strength: EQ 1MG BASE/ML
Dosage Form(s) / Route(s): Solution;oral
Company: Novitium Pharma
Approval Date: 29 July 2024
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for:
- The treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
- The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction.
Approved Label: 29 July 2024 (PDF)