FDA — authorised 23 April 2014
- Application: ANDA201273
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
🇺🇸 Nicotinic Acid in United States
FDA authorised Nicotinic Acid on 23 April 2014 · 6,858 US adverse-event reports
Marketing authorisations
FDA — authorised 23 April 2014
- Application: ANDA200484
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA204178
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: Nicotinic Acid
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA203899
- Marketing authorisation holder: LANNETT CO INC
- Status: approved
FDA — authorised 1 February 2018
- Application: ANDA209236
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 3 March 2022
- Application: ANDA204934
- Marketing authorisation holder: MACLEODS PHARMS 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: 6,858
Most-reported reactions
- Drug Ineffective — 940 reports (13.71%)
- Nausea — 849 reports (12.38%)
- Fatigue — 838 reports (12.22%)
- Diarrhoea — 711 reports (10.37%)
- Pain — 670 reports (9.77%)
- Dizziness — 627 reports (9.14%)
- Headache — 619 reports (9.03%)
- Dyspnoea — 580 reports (8.46%)
- Drug Hypersensitivity — 529 reports (7.71%)
- Asthenia — 495 reports (7.22%)
Nicotinic Acid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Nicotinic Acid approved in United States?
Yes. FDA authorised it on 23 April 2014; FDA authorised it on 23 April 2014; FDA authorised it on 11 December 2015.
Who is the marketing authorisation holder for Nicotinic Acid in United States?
SUN PHARM holds the US marketing authorisation.