Is Nateglinide approved by the US FDA?

Drugs@FDA lists 9 application product lines for Nateglinide, including NATEGLINIDE (Prescription); NATEGLINIDE (Prescription); NATEGLINIDE (Prescription); NATEGLINIDE (Prescription); NATEGLINIDE (Prescription).

Is Nateglinide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Nateglinide.

Are there safety signals or safety updates for Nateglinide?

US FDA: 1 entry (latest 2021-10-28).

Active substance

Nateglinide

US FDA 9
EMA 2
US price lines 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NATEGLINIDE	60MG; 120MG	tablet · oral	DR REDDYS LABS LTD	Prescription	9 Sep 2009
NATEGLINIDE	60MG; 120MG	tablet · oral	STRIDES PHARMA INTL	Prescription	9 Sep 2009
NATEGLINIDE	60MG; 120MG	tablet · oral	WATSON LABS	Prescription	30 Mar 2011
NATEGLINIDE	60MG; 120MG	tablet · oral	ZYDUS PHARMS	Prescription	6 Jul 2016
NATEGLINIDE	60MG; 120MG	tablet · oral	RISING	Prescription	18 Jun 2018
NATEGLINIDE	60MG; 120MG	tablet · oral	CADILA PHARMS LTD	Prescription	19 Apr 2019
STARLIX	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	NOVARTIS	Discontinued	22 Dec 2000
NATEGLINIDE	60MG; 120MG	tablet · oral	ALVOGEN	Discontinued	11 Dec 2015
NATEGLINIDE	60MG; 120MG	tablet · oral	TEVA PHARMS	Discontinued

EMA European Union — centrally authorised medicines

Starlix Novartis Europharm Limited · Withdrawn · authorised 3 Apr 2001 · ATC A10BX03

Therapeutic indication (EMA)

Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.

Trazec Novartis Europharm Ltd. · Lapsed · authorised 3 Apr 2001 · ATC A10BX03

Therapeutic indication (EMA)

Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NATEGLINIDE 120 MG TABLET	$0.22218	per EA	23 Sep 2026
US NADAC	NATEGLINIDE 60 MG TABLET	$0.1794	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Oct 2021 STARLIX — safety-related labeling change
Labeling sections changed: Contraindications; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for nateglinide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.