The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.
Enforcement Report - Week of February 1, 2023
The Food and Drug Administration has rejected Supernus Pharmaceuticals’ drug infusion device for Parkinson’s disease, the company revealed on Monday.
Celera Neuro Sciences has now brought into India, third-generation apomorphine pumps and pens used in western countries manufactured by German pharma major Ever Pharma for the treatment of Parkinson’s disease.
Sage Pharms' Generic Apomorphine Hydrochloride Receives Approval in the U.S.
ROCKVILLE, Md., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company’s New Drug Application (NDA) resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease is considered a Standard Review thereby assigning a timeline of 10 months for review by the FDA and establishing a Prescription Drug User Fee Act (PDUFA) target action date in early October 2022.
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has entered into an agreement with BIAL in which Sunovion has granted exclusive commercial license rights in Europe for apomorphine sublingual film (APL-130277). APL-130277, approved as KYNMOBI® (apomorphine hydrochloride) sublingual film in the U.S. and Canada, is a novel thin film formulation of apomorphine that dissolves under the tongue for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). APL-130277 is currently in Phase 3 clinical development in Europe.
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc.. (Sunovion) today announced that KYNMOBI™ (apomorphine HCI) sublingual film is now available in the U.S. by prescription for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). KYNMOBI is a novel thin film formulation of apomorphine that dissolves under the tongue to treat OFF episodes in patients with PD as they occur. KYNMOBI was approved by the U.S. Food and Drug Administration (FDA) on May 21, 2020 and its commercial activities initiated on September 29, 2020.
MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. Inc. (Sunovion) announced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. They may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms. These disruptive episodes can occur any time throughout the day and get worse as the disease progresses. KYNMOBI was previously approved by the U.S. Food and Drug Administration (FDA) on May 21, 2020.