HAYWARD, CA.,USA I April 11, 2014 I Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax’s New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson’s disease (PD).
After discussions with the FDA, the Company has resubmitted the NDA for RYTARY providing updated safety and stability information. The FDA will require an inspection of manufacturing facilities involved in the production of RYTARY in connection with the resubmission. The FDA has designated the NDA filing for RYTARY as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.
“We are excited to resubmit the updated NDA for RYTARY and remain enthusiastic about the potential commercial opportunity for the product,” said Michael Nestor, president of Impax Pharmaceuticals.
About RYTARY (IPX066)
RYTARY is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
About Parkinson’s Disease
Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company’s Web site at: www.impaxlabs.com.
SOURCE: Impax Laboratories
Post Views: 152
HAYWARD, CA.,USA I April 11, 2014 I Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax’s New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson’s disease (PD).
After discussions with the FDA, the Company has resubmitted the NDA for RYTARY providing updated safety and stability information. The FDA will require an inspection of manufacturing facilities involved in the production of RYTARY in connection with the resubmission. The FDA has designated the NDA filing for RYTARY as a Class 2 resubmission for review purposes and has 14 calendar days to officially accept the NDA resubmission.
“We are excited to resubmit the updated NDA for RYTARY and remain enthusiastic about the potential commercial opportunity for the product,” said Michael Nestor, president of Impax Pharmaceuticals.
About RYTARY (IPX066)
RYTARY is an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
About Parkinson’s Disease
Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company’s Web site at: www.impaxlabs.com.
SOURCE: Impax Laboratories
Post Views: 152
