03 Feb 2025
// FDA
11 Mar 2024
// DRUG STORE NEWS
26 Feb 2024
// PR NEWSWIRE
Aucta is a global brand that creates better products from proven molecules.
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CPhI North America CPhI North America
Industry Trade Show
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20-22 May, 2025
CPhI WW FrankfurtCPhI WW Frankfurt
Industry Trade Show
Attending
28-30 October, 2025
Industry Trade Show
Attending
05-09 December, 2025
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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
30 Nov 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215332
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
Therapeutic Area: Neurology Brand Name: Motpoly XR
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2024
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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
Therapeutic Area: Neurology Brand Name: Trileptal-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2022
Lead Product(s) : Oxcarbazepine
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
May 12, 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
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Perforomist-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 12, 2022
Lead Product(s) : Formoterol Fumarate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
January 12, 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
Therapeutic Area: Hematology Brand Name: Jadenu
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Oakrum Pharma, LLC
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2021
Lead Product(s) : Deferasirox
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 : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2021
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INHALATION
Brand Name : ARFORMOTEROL TARTRATE
Dosage Strength : EQ 0.015MG BASE/2ML
Packaging :
Approval Date : 2025-02-03
Application Number : 218380
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : GRANULE;ORAL
Brand Name : DEFERASIROX
Dosage Strength : 180MG
Packaging :
Approval Date : 2021-03-09
Application Number : 214559
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : GRANULE;ORAL
Brand Name : DEFERASIROX
Dosage Strength : 90MG
Packaging :
Approval Date : 2021-03-09
Application Number : 214559
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : GRANULE;ORAL
Brand Name : DEFERASIROX
Dosage Strength : 360MG
Packaging :
Approval Date : 2021-03-09
Application Number : 214559
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Oral Granule
Brand Name :
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Inhalation Solution
Brand Name :
Dosage Strength : 20MCG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, EXTENDED RELEAS...
Brand Name : MOTPOLY XR
Dosage Strength : 150MG
Packaging :
Approval Date : 2023-05-04
Application Number : 216185
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, EXTENDED RELEAS...
Brand Name : MOTPOLY XR
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-05-04
Application Number : 216185
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : CAPSULE, EXTENDED RELEAS...
Brand Name : MOTPOLY XR
Dosage Strength : 200MG
Packaging :
Approval Date : 2023-05-04
Application Number : 216185
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Extended Release Capsule
Brand Name : Motpoly XR
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
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 : GRANULE; ORAL
Proprietary Name : DEFERASIROX
Dosage Strength : 90MG
Approval Date : 2021-03-09
Application Number : 214559
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : GRANULE; ORAL
Proprietary Name : DEFERASIROX
Dosage Strength : 180MG
Approval Date : 2021-03-09
Application Number : 214559
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : GRANULE; ORAL
Proprietary Name : DEFERASIROX
Dosage Strength : 360MG
Approval Date : 2021-03-09
Application Number : 214559
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 : 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
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Oral Granule
Brand Name :
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Inhalation Solution
Brand Name :
Dosage Strength : 20MCG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Extended Release Capsule
Brand Name : Motpoly XR
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Oral Suspension
Brand Name :
Dosage Strength : 300MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
Regulatory Info :
Registration Country : U.S.A
Dosage Form : Oral Solution
Brand Name : Vigadrone
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : U.S.A
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