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APL-130277 Approval Status

FDA Approved: No
Brand name: APL-130277
Generic name: apomorphine
Dosage form: Sublingual Film
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

APL-130277 (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine in development for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

Development Status and FDA Approval Process for APL-130277

DateArticle
Dec 20, 2019Sunovion Announces FDA Filing Acceptance of Resubmitted New Drug Application for Apomorphine Sublingual Film
Nov 22, 2019Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film
Jan 30, 2019Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)
Jun 12, 2018Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

Further information

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