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08-10 October, 2024
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26-27 September, 2024
Oligo Chemistry & Ther...Oligo Chemistry & Therapeutics 2024
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27 September, 2024
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CPhI Worldwide, MilanCPhI Worldwide, Milan
Industry Trade Show
Not Confirmed
08-10 October, 2024
Industry Trade Show
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26-27 September, 2024
Oligo Chemistry & Ther...Oligo Chemistry & Therapeutics 2024
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27 September, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/ice-is-pioneering-sustainability-innovation-in-bile-acid-research-for-neurodegenerative-diseases
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/2024-us-elections-harris-trump-differ-on-abortion-rights-aca-public-health-spends-agree-on-need-to-cut-drug-prices
10 Jul 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215203
08 May 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216801
01 Apr 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/04/01/2855070/0/en/Sol-Gel-s-Collaboration-Partner-First-to-File-ANDA-Drug-Product-Generic-to-Zoryve-Cream.html
13 Dec 2023
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-13-2023-38736.pdf
08 Nov 2023
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-8-2023-82126.pdf
01 Nov 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212657
Details:
Zoryve-Generic (roflumilast), PDE4 Inhibitor, small molecule. It is a topical cream indicated for the treatment of plaque psoriasis in patients six years of age and older.
Lead Product(s): Roflumilast
Therapeutic Area: Dermatology Brand Name: Zoryve-Generic
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Sol-Gel Technologies
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2024
Lead Product(s) : Roflumilast
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sol-Gel Technologies
Deal Size : Not Applicable
Deal Type : Not Applicable
Sol-Gel's Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream
Details : Zoryve-Generic (roflumilast), PDE4 Inhibitor, small molecule. It is a topical cream indicated for the treatment of plaque psoriasis in patients six years of age and older.
Brand Name : Zoryve-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 01, 2024
Details:
Brinzolamide, generic equivalent to the Reference Listed Drug Azopt Ophthalmic Suspension, is indicated to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma.
Lead Product(s): Brinzolamide
Therapeutic Area: Ophthalmology Brand Name: Azopt-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Lead Product(s) : Brinzolamide
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces the Launch of Brinzolamide Ophthalmic Suspension with CGT Exclusivity
Details : Brinzolamide, generic equivalent to the Reference Listed Drug Azopt Ophthalmic Suspension, is indicated to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma.
Brand Name : Azopt-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2023
Details:
Naloxone HCl Nasal Spray is the opioid antagonists indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Narcan-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Naloxone HCl Nasal Spray is the opioid antagonists indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Brand Name : Narcan-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 08, 2023
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites, which is investigated for the treatment of Multiple Sclerosis.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Narcan-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2023
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces the First Generic Over-the-Counter Approval of a Naloxone Nasal Spray Product
Details : Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites, which is investigated for t...
Brand Name : Narcan-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 19, 2023
Details:
Budesonide is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission).
Lead Product(s): Budesonide
Therapeutic Area: Gastroenterology Brand Name: Uceris-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Lead Product(s) : Budesonide
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces FDA Approval and Launch of A-Rated Generic Version of Uceris® (budesonide 2 Mg ...
Details : Budesonide is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission).
Brand Name : Uceris-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 28, 2023
Details:
Under the agreement Padagis is granted exclusive rights to market and sell MOB-015 (terbinafine hydrochloride) in Israel and the Palestinian territories. Moberg Pharma assumes production and supply responsibility.
Lead Product(s): Terbinafine Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: MOB-015
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Moberg Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 04, 2022
Lead Product(s) : Terbinafine Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Recipient : Moberg Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Moberg Pharma and Padagis Sign Agreement For MOB-015 in Israel
Details : Under the agreement Padagis is granted exclusive rights to market and sell MOB-015 (terbinafine hydrochloride) in Israel and the Palestinian territories. Moberg Pharma assumes production and supply responsibility.
Brand Name : MOB-015
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 04, 2022
Details:
Naloxone Nasal Spray, 4mg (generic to Narcan®),is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Naloxone-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces 3 Major Product Launches
Details : Naloxone Nasal Spray, 4mg (generic to Narcan®),is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
Brand Name : Naloxone-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 21, 2022
Details:
Tobradex® Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Lead Product(s): Tobramycin,Dexamethasone
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Lead Product(s) : Tobramycin,Dexamethasone
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces The FDA Approval And Launch Of an Ab Rated Generic Version Of Tobradex® Ophthal...
Details : Tobradex® Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 21, 2022
Details:
Tobramycin (generic to Tobradex) Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Lead Product(s): Tobramycin,Dexamethasone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Tobramycin / Dexamethasone-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Lead Product(s) : Tobramycin,Dexamethasone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces the FDA Approval and Launch of an AB Rated Generic Version of Tobradex® Ophthal...
Details : Tobramycin (generic to Tobradex) Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exi...
Brand Name : Tobramycin / Dexamethasone-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 21, 2022
Details:
Zomig® Nasal Spray is distributed in a unique unit dose presentation and is indicated for the treatment of migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age).
Lead Product(s): Zolmitriptan
Therapeutic Area: Neurology Brand Name: Zomig
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Lead Product(s) : Zolmitriptan
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Padagis Announces the First-to-Market Launch of an AB Rated Generic Version Of Zomig® Nasal Spray
Details : Zomig® Nasal Spray is distributed in a unique unit dose presentation and is indicated for the treatment of migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age).
Brand Name : Zomig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 16, 2021
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-03-20
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-03-20
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-11-19
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-11-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-02-06
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-02-06
District Decision : No Action Indicated
Inspection End Date : 2013-02-06
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2013-02-06
District Decision : No Action Indicated
Inspection End Date : 2013-11-06
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-11-06
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-07-07
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-07-07
District Decision : No Action Indicated
Inspection End Date : 2019-10-23
City : Minneapolis
State : MN
Country/Area : US
Zip : 55427-1244
District : Padagis US LLC
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2019-10-23
District Decision : No Action Indicated
Inspection End Date : 2010-01-28
City : Yerucham
State :
Country/Area : IL
Zip :
District : Padagis Israel Pharmaceuticals Ltd.
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2010-01-28
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-08-27
City : Yerucham
State :
Country/Area : IL
Zip :
District : Padagis Israel Pharmaceuticals Ltd.
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-08-27
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-01-22
City : Yerucham
State :
Country/Area : IL
Zip :
District : Padagis Israel Pharmaceuticals Ltd.
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-01-22
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