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pancreaze

Generic: pancrelipase

pancreaze: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

pancreaze evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect pancreaze to VVUS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could pancreaze → VVUS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Exocrine pancreatic insufficiency (EPI)
Development Pipeline (1)
CompanyPhase
VIVUS INC (VVUS)
Exocrine pancreatic insufficiency (EPI)
Approved
Clinical Trials (1)

A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)

NCT01652157·ABBV
Terminated

Primary endpoint: Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP

Observational17 targetStarted 2012-07Completion 2020-0450 sites · United StatesAbbVie
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )(VVUS)FDA ↗
BLA022523Type 7 - Drug Already Marketed without Approved NDAStandardOralCapsule, Delayed Release

Frequently asked questions

Who is developing pancreaze?

pancreaze is being developed by VIVUS INC.

How many clinical trials involve pancreaze?

BioSniper tracks 1 clinical trial involving pancreaze.

What is pancreaze's latest FDA decision?

The most recent tracked FDA decision for pancreaze is Approval for 1 INDICATIONS AND USAGE PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 ), dated April 12, 2010.