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    Company profile for Akorn Pharmaceuticals

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    End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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    About

    Akorn Inc. is niche generic pharmaceutical company engaged in development, manufacture and marketing of pharmaceuticals like Ophthalmologic Solutions, Ointments, Gels and Injectables, Injectables like Antidotes,Anti-infectives & Controlled substances.Akorn has its US-FDA approved manufacturing facilities at Decatur and Somerset in USA and R&D Centre at Vernon Hills, USA.Akorn India Private Limited is a leading Global Sterile ...
    Akorn Inc. is niche generic pharmaceutical company engaged in development, manufacture and marketing of pharmaceuticals like Ophthalmologic Solutions, Ointments, Gels and Injectables, Injectables like Antidotes,Anti-infectives & Controlled substances.Akorn has its US-FDA approved manufacturing facilities at Decatur and Somerset in USA and R&D Centre at Vernon Hills, USA.Akorn India Private Limited is a leading Global Sterile Contract Manufacturer spread over 60,000 sq. meters with 5 dedicated blocks for Cephalosporins, Carbapenems, Hormones, General liquid fill sterile Injectables.

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    Akorn PharmaceuticalsUnited_States_of_America Flag
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    U.S.A
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    1925 W. Field Court, Suite 300, Lake Forest, Illinois 60045
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    1-800-932-5676
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    enquiries@pharmacompass.com
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    https://www.akorn.com/
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    NEWS #PharmaBuzz

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    Akorn’s bankruptcy, recalls bring a drug to treat lead poisoning into shortage
    Akorn’s bankruptcy, recalls bring a drug to treat lead poisoning into shortage

    27 Jul 2023

    // Tyler Patchen ENDPTS

    https://endpts.com/akorn-pharmaceuticals-bankruptcy-recalls-cause-lead-poisoning-drug-shortage/

    Tyler Patchen ENDPTS
    27 Jul 2023
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    Akorn's Generic Ciprofloxacin, Dexamethasone Receives Approval in the U.S.
    Akorn's Generic Ciprofloxacin, Dexamethasone Receives Approval in the U.S.

    09 Jun 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215768

    FDA
    09 Jun 2023
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    Enforcement Report - Week of June 7, 2023
    Enforcement Report - Week of June 7, 2023

    07 Jun 2023

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

    FDA
    07 Jun 2023
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    Akorn Issues Voluntary Nationwide Recall of Various Human & Animal Drug Products
    Akorn Issues Voluntary Nationwide Recall of Various Human & Animal Drug Products

    03 May 2023

    // BUSINESSWIRE

    https://www.prnewswire.com/news-releases/akorn-issues-voluntary-nationwide-recall-of-various-human-and-animal-drug-products-within-expiry-due-to-company-shutdown-301815349.html

    BUSINESSWIRE
    03 May 2023
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    Thea Pharma Statement Related to Akorn's Recall of Various Human & Animal Drug
    Thea Pharma Statement Related to Akorn's Recall of Various Human & Animal Drug

    28 Apr 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/thea-pharma-inc-statement-related-to-akorns-voluntary-nationwide-recall-of-various-human-and-animal-drug-branded-ophthalmic-products-within-expiry-due-to-company-shutdown-301811331.html

    PR NEWSWIRE
    28 Apr 2023
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    After Akorn's site closures in the US, albuterol remains in shortage
    After Akorn's site closures in the US, albuterol remains in shortage

    31 Mar 2023

    // Tyler Patchen ENDPTS

    https://endpts.com/after-akorns-site-closures-in-the-us-albuterol-remains-in-shortage/

    Tyler Patchen ENDPTS
    31 Mar 2023
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    Drugs in Development

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    Akorn Introduces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg at ASRM

    Details:

    Cetrorelix Acetate is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called GnRH. GnRH controls the secretion of another hormone, called LH, which induces ovulation during the menstrual cycle.


    Lead Product(s): Cetrorelix Acetate

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Cetrorelix Acetate-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 27, 2022

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    Lead Product(s) : Cetrorelix Acetate

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Akorn Introduces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg at ASRM

    Details : Cetrorelix Acetate is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called GnRH. GnRH controls the secretion of another hormone, called LH, which induces ovulation during th...

    Product Name : Cetrorelix Acetate-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 27, 2022

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    Akorn Announces FDA-Approved Generic Cetrorelix Acetate for Injection 0.25 mg

    Details:

    Cetrorelix Acetate for Injection 0.25 mg is used to prevent premature ovulation during controlled ovarian stimulation, for Injection blocks such undesirable premature ovulation.


    Lead Product(s): Cetrorelix Acetate

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Cetrorelix Acetate-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 16, 2022

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    Akorn Pharmaceuticals

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    Lead Product(s) : Cetrorelix Acetate

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Akorn Announces FDA-Approved Generic Cetrorelix Acetate for Injection 0.25 mg

    Details : Cetrorelix Acetate for Injection 0.25 mg is used to prevent premature ovulation during controlled ovarian stimulation, for Injection blocks such undesirable premature ovulation.

    Product Name : Cetrorelix Acetate-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 16, 2022

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    Akorn Announces Completion of the Sale of its Branded Ophthalmic Products to Théa Pharma

    Details:

    Under the deal, Théa Pharma acquired seven products including established glaucoma therapies Zioptan®, Cosopt®, Cosopt® PF, and Betimol®, along with Azasite®, Akten®, and the ocular surface repair agent AcellFX™.


    Lead Product(s): Tafluprost

    Therapeutic Area: Ophthalmology Brand Name: Zioptan

    Study Phase: Approved FDFProduct Type: HPAPI

    Sponsor: Thea pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition March 09, 2022

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    Lead Product(s) : Tafluprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Thea pharma

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Akorn Announces Completion of the Sale of its Branded Ophthalmic Products to Théa Pharma

    Details : Under the deal, Théa Pharma acquired seven products including established glaucoma therapies Zioptan®, Cosopt®, Cosopt® PF, and Betimol®, along with Azasite®, Akten®, and the ocular surface repair agent AcellFX™.

    Product Name : Zioptan

    Product Type : HPAPI

    Upfront Cash : Undisclosed

    March 09, 2022

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    Théa to Acquire Branded Ophthalmic Products from Akorn, Expanding Théa’s Presence into the U.S. Eye Care Industry

    Details:

    The purchase will add seven established brands, including Akorn’s leading glaucoma therapy, Zioptan®, to Théa’s portfolio. Théa will also welcome Akorn’s nearly 50-person sales force, which Théa expects to expand in support of anticipated growth and launches of additional products in the U.S.


    Lead Product(s): Tafluprost

    Therapeutic Area: Ophthalmology Brand Name: Zioptan

    Study Phase: Approved FDFProduct Type: HPAPI

    Sponsor: Laboratoires Thea

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition January 28, 2022

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    Akorn Pharmaceuticals

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    Lead Product(s) : Tafluprost

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Laboratoires Thea

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Théa to Acquire Branded Ophthalmic Products from Akorn, Expanding Théa’s Presence into the U.S...

    Details : The purchase will add seven established brands, including Akorn’s leading glaucoma therapy, Zioptan®, to Théa’s portfolio. Théa will also welcome Akorn’s nearly 50-person sales force, which Théa expects to expand in support of anticipated growt...

    Product Name : Zioptan

    Product Type : HPAPI

    Upfront Cash : Undisclosed

    January 28, 2022

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    Akorn Announces Agreement to Sell its Consumer Health Business to Prestige Consumer Healthcare

    Details:

    The Consumer Health business primarily consists of the following over-the-counter brands: TheraTears , Diabetic Tussin , MagOx , Multi-betic , and Zostrix.


    Lead Product(s): Croscarmellose Sodium API

    Therapeutic Area: Ophthalmology Brand Name: TheraTears

    Study Phase: Approved FDFProduct Type: Carbohydrate

    Sponsor: Prestige Consumer Healthcare

    Deal Size: $230.0 million Upfront Cash: $230.0 million

    Deal Type: Divestment May 27, 2021

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    Akorn Pharmaceuticals

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    Lead Product(s) : Croscarmellose Sodium API

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Prestige Consumer Healthcare

    Deal Size : $230.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Akorn Announces Agreement to Sell its Consumer Health Business to Prestige Consumer Healthcare

    Details : The Consumer Health business primarily consists of the following over-the-counter brands: TheraTears , Diabetic Tussin , MagOx , Multi-betic , and Zostrix.

    Product Name : TheraTears

    Product Type : Carbohydrate

    Upfront Cash : $230.0 million

    May 27, 2021

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    Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.5%

    Details:

    Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.


    Lead Product(s): Loteprednol Etabonate

    Therapeutic Area: Ophthalmology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 11, 2021

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    Lead Product(s) : Loteprednol Etabonate

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.5%

    Details : Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    February 11, 2021

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    Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

    Details:

    Clindamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acne Vulgaris.


    Lead Product(s): Clindamycin Hydrochloride

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Antibiotic

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 11, 2018

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    Lead Product(s) : Clindamycin Hydrochloride

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

    Details : Clindamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acne Vulgaris.

    Product Name : Undisclosed

    Product Type : Antibiotic

    Upfront Cash : Inapplicable

    May 11, 2018

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    Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

    Details:

    Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoarthritis, Knee.


    Lead Product(s): Diclofenac Sodium

    Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 23, 2016

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    Lead Product(s) : Diclofenac Sodium

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

    Details : Diclofenac Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Osteoarthritis, Knee.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 23, 2016

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    Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops

    Details:

    TheraTears (Sodium Carboxymethylcellulose) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.


    Lead Product(s): Croscarmellose Sodium API

    Therapeutic Area: Ophthalmology Brand Name: TheraTears

    Study Phase: Phase IVProduct Type: Carbohydrate

    Recipient: Koffler Vision Group

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 02, 2016

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    Akorn Pharmaceuticals

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    Lead Product(s) : Croscarmellose Sodium API

    Therapeutic Area : Ophthalmology

    Highest Development Status : Phase IV

    Recipient : Koffler Vision Group

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops

    Details : TheraTears (Sodium Carboxymethylcellulose) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Dry Eye Syndromes.

    Product Name : TheraTears

    Product Type : Carbohydrate

    Upfront Cash : Inapplicable

    May 02, 2016

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    Bioequivalence Study for Benzyl Alcohol Lotion 5%.

    Details:

    Benzyl Alcohol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pediculus.


    Lead Product(s): Benzyl Alcohol

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: South Florida Family Health and Research Centers | Axis Clinicals Ltd.

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 09, 2015

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    Akorn Pharmaceuticals

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    Lead Product(s) : Benzyl Alcohol

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : South Florida Family Health and Research Centers | Axis Clinicals Ltd.

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study for Benzyl Alcohol Lotion 5%.

    Details : Benzyl Alcohol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pediculus.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 09, 2015

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