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Kynmobi Approval History

FDA Approved: Yes (First approved May 21, 2020)
Brand name: Kynmobi
Generic name: apomorphine hydrochloride
Dosage form: Sublingual Film
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

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

Development History and FDA Approval Process for Kynmobi

DateArticle
May 21, 2020Approval FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes
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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