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// PR NEWSWIRE
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CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
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14-17 October, 2024
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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
25 Nov 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216486
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
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Motpoly
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Lead Product(s) : Oxcarbazepine
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Trileptal-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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
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
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
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...
Brand Name : Formoterol Fumarate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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
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
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
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.
Brand Name : Jadenu
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2021
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 : 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 :
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 : 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 : 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 :
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 : RX
Registration Country : USA
Dosage Form : SUSPENSION;ORAL
Brand Name : OXCARBAZEPINE
Dosage Strength : 300MG/5ML
Packaging :
Approval Date : 2022-11-30
Application Number : 215332
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : FOR SOLUTION;ORAL
Brand Name : VIGADRONE
Dosage Strength : 500MG/PACKET
Packaging :
Approval Date : 2018-06-21
Application Number : 210196
Regulatory Info : RX
Registration Country : USA
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