Date: 2014-08-04
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:
Action mechanism:
Disease: Parkinson\'s disease
Details: * On August 4, 2014, Impax Laboratories announced that the FDA performed a re-inspection of the Company\'s Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these observations and, pursuant to its established regulatory process, will defer classification until it has reviewed the Company\'s response to the inspection. The Company is working to address FDA\'s observations and will respond to them within 15 days of receipt of the Form 483. The Company has provided a redacted version of the Form 483 as an exhibit in a Current Report on Form 8-K filed with the SEC. * On January 21, 2013, Impax has announced the receipt of a complete response letter from the FDA indicating that the agency required a satisfactory re-inspection of its Hayward manufacturing facility before the RYTARY™ NDA may be approved. The company then announced the receipt of a Form 483 following an inspection of Hayward that hold up approval of the drug.
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