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FDA Calendar for A.P. Pharma, Inc. (APPA)
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A.P. Pharma, Inc. (A.P. Pharma) is a specialty pharmaceutical company focused on developing pharmaceutical products using its Biochronomer polymer-based drug delivery technology. The Company’s primary focus is on its lead product candidate, APF530, which completed a pivotal Phase III clinical trial for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the year ended December 31, 2008. APF530 is designed to prevent CINV for at least five days and contains granisetron, a drug approved for the prevention of CINV. In addition to its lead drug candidate, A.P. Pharma has a pipeline of other product candidates that use its Biochronomer technology. One of these, APF112, incorporates the local anesthetic, mepivacaine. It is designed to provide up to 36 hours of post-surgical pain relief and to minimize the use of morphine-like drugs, or opiates, which are used in post-surgical pain management.
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Drug Pipeline
Drug Name
Type Of Drug
FDA Status
Drug Phase
APF530
Other
Pending Decision
NDA
Test 1
Other
Pending Decision
Phase 3
Events
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Outcome
Past Events
A.P. Pharma, Inc.
03/18/2010
Past Event
FDA Decision:
PDUFA date for APF530.
(relates to the drug
APF530
)
FDA asking for more studies. APF530 was not approved.
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