30 Jun 2025
// FDA
03 Feb 2025
// FDA
11 Mar 2024
// DRUG STORE NEWS
Aucta is a global brand that creates better products from proven molecules.
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Webinars & Exhibitions
Industry Trade Show
Not Confirmed
24-26 February, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
CORPORATE CONTENT #SupplierSpotlight

30 Jun 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219417

03 Feb 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218380

11 Mar 2024
// DRUG STORE NEWS

26 Feb 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/aucta-pharmaceuticals-inc-aucta-pharmaceuticals-launches-motpoly-xr-lacosamide-extended-release-capsules-c-v-the-first-and-only-once-daily-formulation-of-lacosamide-302070783.html

05 Dec 2022
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/aucta-announced-fda-approval-of-a-generic-version-of-trileptaloxcarbazepine-oral-suspension-301694327.html#:~:text=PISCATAWAY%2C%20N.J.%2C%20Dec.,this%20product%20in%20early%202023.

01 Dec 2022
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/aucta-announces-fda-approval-of-a-generic-version-of-perforomist-formoterol-fumarate-inhalation-solution-301691187.html
Details:
Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.
Lead Product(s): Lacosamide,Inapplicable
Therapeutic Area: Neurology Brand Name: Motpoly XR
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2024
Lead Product(s) : Lacosamide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aucta Launches MOTPOLY XR, the First Once-Daily Lacosamide Formulation
Details : Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.
Product Name : Motpoly XR
Product Type : Controlled Substance
Upfront Cash : Inapplicable
February 26, 2024
Details:
Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat partial seizures.
Lead Product(s): Oxcarbazepine,Inapplicable
Therapeutic Area: Neurology Brand Name: Trileptal-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2022
Lead Product(s) : Oxcarbazepine,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aucta Announced FDA Approval of A Generic Version of Trileptal®(oxcarbazepine) Oral Suspension
Details : Oxcarbazepine produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. It is indicated to treat parti...
Product Name : Trileptal-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 05, 2022
Details:
Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).
Lead Product(s): Formoterol Fumarate,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Perforomist-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 01, 2022
Lead Product(s) : Formoterol Fumarate,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aucta Announces FDA Approval Of A Generic Version Of Perforomist® (formoterol fumarate) Inhalatio...
Details : Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchiti...
Product Name : Perforomist-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 01, 2022
Details:
JADENU (deferasirox) tablets for oral use and JADENU® Sprinkle (deferasirox) granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Lead Product(s): Deferasirox,Inapplicable
Therapeutic Area: Hematology Brand Name: Jadenu
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Oakrum Pharma, LLC
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2021
Lead Product(s) : Deferasirox,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Oakrum Pharma, LLC
Deal Size : Inapplicable
Deal Type : Inapplicable
Oakrum Pharma and Aucta Pharma Announce U.S. FDA Approval of Generic Version of JADENU® Sprinkle ...
Details : JADENU (deferasirox) tablets for oral use and JADENU® Sprinkle (deferasirox) granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Product Name : Jadenu
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 22, 2021
Details:
Sirolimus is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Facial Angiofibroma.
Lead Product(s): Sirolimus,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2017
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex
Details : Sirolimus is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Facial Angiofibroma.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 06, 2017
Details:
Entecavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B.
Lead Product(s): Entecavir,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2017
Lead Product(s) : Entecavir,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Entecavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis B.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 04, 2017
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]RLD : No
TE Code : AN
Dosage Form : SOLUTION; INHALATION
Proprietary Name : ARFORMOTEROL TARTRATE
Dosage Strength : EQ 0.015MG BASE/2ML
Approval Date : 2025-02-03
Application Number : 218380
RX/OTC/DISCN : RX
RLD : No
TE Code : AN
RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : PYQUVI
Dosage Strength : 22.75MG/ML
Approval Date : 2025-06-30
Application Number : 219417
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : MOTPOLY XR
Dosage Strength : 100MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : MOTPOLY XR
Dosage Strength : 150MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : CAPSULE, EXTENDED RELEASE; ORA...
Proprietary Name : MOTPOLY XR
Dosage Strength : 200MG
Approval Date : 2023-05-04
Application Number : 216185
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Dosage Form : SUSPENSION; ORAL
Proprietary Name : OXCARBAZEPINE
Dosage Strength : 300MG/5ML
Approval Date : 2022-11-30
Application Number : 215332
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : POWDER; ORAL
Proprietary Name : ZELVYSIA
Dosage Strength : 100MG/PACKET
Approval Date : 2025-04-29
Application Number : 218645
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : POWDER; ORAL
Proprietary Name : ZELVYSIA
Dosage Strength : 500MG/PACKET
Approval Date : 2025-04-29
Application Number : 218645
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AA
Dosage Form : FOR SOLUTION; ORAL
Proprietary Name : VIGADRONE
Dosage Strength : 500MG/PACKET
Approval Date : 2018-06-21
Application Number : 210196
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
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