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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Nortriptyline

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 25, 2021

            Details:

            Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Nortriptyline Hydrochloride capsules USP, in strengths of 10 mg, 25 mg, 50 mg and 75 mg, Cadila Healthcare said in a regulatory filing.

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            Lead Product(s): Tadalafil

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 31, 2020

            Details:

            Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.

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            Lead Product(s): Asenapine Maleate

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 11, 2020

            Details:

            The approved ANDA is therapeutically equivalent to the reference listed drug product, Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan. Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.

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            Lead Product(s): Olanzapine

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder. The drug may also be used in combination with other medication to treat depression and certain mental conditions.