Date: 2014-07-29
Type of information: Validation of a production plant
Compound: Rytary™ (extended-release capsule formulation of carbidopa and levodopa)
Company: Impax Laboratories (USA - CA)
Therapeutic area: Neurodegenerative diseases
Type agreement: inspection of a production plant
Action mechanism: Rytary™ is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson\'s disease.
Disease: Parkinson\'s disease
Details: * On July 29, 2014, Impax Laboratories announced that the FDA performed a general GMP inspection and a Pre-Approval Inspection (PAI) for Rytary™ at the company\'s Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States. The FDA did not provide any status or classification to these observations and, as is normal practice, will wait until they have received and reviewed the Company\'s response to provide this information. The Company has also not been informed by the FDA of the impact this Form 483 may have on Rytary™ October 9, 2014 review date under the Prescription Drug User Fee Act (PDUFA). Results from the phase III studies of Rytary™, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
Financial terms:
Latest news:
