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    Novugen’s Generics Everolimus Receives Approval in US
    Novugen’s Generics Everolimus Receives Approval in US

    30 Oct 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219955

    FDA
    30 Oct 2025
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    Hikma acquires Novugen's FDA-approved ANDA for trametinib
    Hikma acquires Novugen's FDA-approved ANDA for trametinib

    17 Apr 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/hikma-acquires-novugens-fda-approved-anda-for-trametinib-302431694.html

    PR NEWSWIRE
    17 Apr 2025
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    Novugen's Generic Pazopanib Hydrochloride Receives Approval in the U.S.
    Novugen's Generic Pazopanib Hydrochloride Receives Approval in the U.S.

    24 Apr 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218231

    FDA
    24 Apr 2024
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    Novugen's Generic Sunitinib Malate Receives Approval in the U.S.
    Novugen's Generic Sunitinib Malate Receives Approval in the U.S.

    21 Aug 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218012

    FDA
    21 Aug 2023
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    Drugs in Development

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    Hikma acquires Novugen's FDA-approved ANDA for trametinib

    Details:

    Through the acquisition, Hikma holds the rights of Mekinist-Generic (trametinib dimethyl sulfoxide) tablets from Novugen. It is being indicated for the treatment of BRAF-mutated melanoma.


    Lead Product(s): Trametinib

    Therapeutic Area: Oncology Brand Name: Mekinist-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Hikma Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition April 17, 2025

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    Lead Product(s) : Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Hikma Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Acquisition

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    Hikma acquires Novugen's FDA-approved ANDA for trametinib

    Details : Through the acquisition, Hikma holds the rights of Mekinist-Generic (trametinib dimethyl sulfoxide) tablets from Novugen. It is being indicated for the treatment of BRAF-mutated melanoma.

    Product Name : Mekinist-Generic

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    April 17, 2025

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    Brand Name : ABIRATERONE ACETATE

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    Brand Name : ABIRATERONE ACETATE

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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2022-01-05

    Application Number : 215947

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ABIRATERONE ACETATE

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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2022-01-05

    Application Number : 215947

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : EVEROLIMUS

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    RLD : No

    TE Code : AB

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : EVEROLIMUS

    Dosage Strength : 2.5MG

    Approval Date : 2025-10-30

    Application Number : 219955

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : EVEROLIMUS

    Dosage Strength : 5MG

    Approval Date : 2025-10-30

    Application Number : 219955

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : EVEROLIMUS

    Dosage Strength : 7.5MG

    Approval Date : 2025-10-30

    Application Number : 219955

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : EVEROLIMUS

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    RLD : No

    TE Code : AB

    EVEROLIMUS

    Novugen

    Dosage Form : TABLET; ORAL

    Proprietary Name : EVEROLIMUS

    Dosage Strength : 10MG

    Approval Date : 2025-10-30

    Application Number : 219955

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : LENALIDOMIDE

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    RLD : No

    TE Code : AB

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : LENALIDOMIDE

    Dosage Strength : 2.5MG

    Approval Date : 2024-09-11

    Application Number : 217281

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : LENALIDOMIDE

    Dosage Strength : 5MG

    Approval Date : 2024-09-11

    Application Number : 217281

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    RLD : No

    TE Code : AB

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : LENALIDOMIDE

    Dosage Strength : 10MG

    Approval Date : 2024-09-11

    Application Number : 217281

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : LENALIDOMIDE

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    RLD : No

    TE Code : AB

    LENALIDOMIDE

    Novugen

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : LENALIDOMIDE

    Dosage Strength : 15MG

    Approval Date : 2024-09-11

    Application Number : 217281

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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