Aucta Pharmaceuticals's list of EU CTD Dossiers, Marketing Authorizations, In, Out Licensing Opportunities & Finished Dosage Formulations (FDF) aggregated by PharmaCompass

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Aucta Pharmaceuticals is an emerging drug product development company focusing on new branded 505(b)(2) products and technology platform-based niche generics. Aucta adopts a branded/generic hybrid model, generating both near-term product revenue and mid- to long-term investment return, aiming to become a significant specialty pharma player in the United States and China marketplace. We focus on developing enhanced products for patients with a therapeutic focus on CNS disorders, as well as Ophthalmics, and Inhalation therapies.

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CPhI Worldwide, Milan

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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-llc-party-content-46886.pdf

    https://www.pharmacompass.com/pdf/party/content/aucta-pharmaceuticals-llc-party-content-1623650142.pdf

NEWS #PharmaBuzz

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Aucta debuts generic Vimpat
Aucta debuts generic Vimpat

11 Mar 2024

// DRUG STORE NEWS

https://drugstorenews.com/aucta-debuts-generic-vimpat

DRUG STORE NEWS
11 Mar 2024

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

PR NEWSWIRE
26 Feb 2024

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.

PR NEWSWIRE
05 Dec 2022

https://www.prnewswire.com/news-releases/aucta-announces-fda-approval-of-a-generic-version-of-perforomist-formoterol-fumarate-inhalation-solution-301691187.html

PRNEWSWIRE
01 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215332

FDA
30 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216486

FDA
25 Nov 2022

Drugs in Development

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Details:

Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for the treatment of partial-onset seizures in adults and in pediatric patients.


Lead Product(s): Lacosamide

Therapeutic Area: Neurology Brand Name: Motpoly

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 26, 2024

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01

Lead Product(s) : Lacosamide

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for the treatment of partial-onset seizures in adults and in pediatric patients.

Brand Name : Motpoly

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 26, 2024

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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: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 05, 2022

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02

Lead Product(s) : Oxcarbazepine

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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...

Brand Name : Trileptal-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 05, 2022

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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: Formoterol Fumarate-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 01, 2022

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03

Lead Product(s) : Formoterol Fumarate

Therapeutic Area : Pulmonary/Respiratory Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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...

Brand Name : Formoterol Fumarate-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 01, 2022

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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: ApprovedProduct Type: Small molecule

Sponsor: Oakrum Pharma, LLC

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 22, 2021

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04

Lead Product(s) : Deferasirox

Therapeutic Area : Hematology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Oakrum Pharma, LLC

Deal Size : Not Applicable

Deal Type : Not Applicable

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.

Brand Name : Jadenu

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 22, 2021

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