FDA — authorised 12 April 2010
- Application: BLA022523
- Marketing authorisation holder: VIVUS INC
- Indication: Type 7 - Drug Already Marketed without Approved NDA
- Status: approved
🇺🇸 PANCRELIPASE in United States
FDA authorised PANCRELIPASE on 12 April 2010 · 1,462 US adverse-event reports
Marketing authorisations
FDA — authorised 1 March 2012
- Application: BLA022542
- Marketing authorisation holder: VIOKACE
- Local brand name: VIOKACE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved PANCRELIPASE for the treatment of pancreatic insufficiency in patients with exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, or other conditions. This approval was granted to VIOKACE under the standard expedited pathway. The application number for this approval is BLA022542.
FDA — authorised 19 November 2014
- Application: BLA020725
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 October 2016
- Application: BLA022175
- Marketing authorisation holder: DIGESTIVE CARE INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 March 2020
- Application: BLA022210
- Marketing authorisation holder: EURAND PHARMA LTD
- Indication: Labeling
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,462
Most-reported reactions
- Diarrhoea — 247 reports (16.89%)
- Nausea — 183 reports (12.52%)
- Vomiting — 145 reports (9.92%)
- Dyspnoea — 142 reports (9.71%)
- Fatigue — 141 reports (9.64%)
- Abdominal Pain — 133 reports (9.1%)
- Pyrexia — 130 reports (8.89%)
- Pain — 116 reports (7.93%)
- Asthenia — 113 reports (7.73%)
- Weight Decreased — 112 reports (7.66%)
PANCRELIPASE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is PANCRELIPASE approved in United States?
Yes. FDA authorised it on 12 April 2010; FDA authorised it on 1 March 2012; FDA authorised it on 19 November 2014.
Who is the marketing authorisation holder for PANCRELIPASE in United States?
VIVUS INC holds the US marketing authorisation.