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Folotyn

pralatrexate · Injection

Prescription NDA TE AP RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Folotyn

Generic name

pralatrexate

Dosage form

Injection

Route

Intravenous

Marketing category

NDA · NDA

Labeler

Acrotech Biopharma Inc

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Pralatrexate	20 mg/mL	1796419	View
Pralatrexate	40 mg/2mL	1796419	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Folate Analog Metabolic Inhibitor [EPC]	EPC	All 21 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

022468

Application type

NDA · New Drug Application

Approval date

September 24, 2009

Sponsor

ACROTECH BIOPHARMA

Products on application

Submissions recorded

Products approved under application 022468.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
022468-001	FOLOTYN	SOLUTION		PRALATREXATE	Prescription	AP	RLD
022468-002	FOLOTYN	SOLUTION		PRALATREXATE	Prescription	AP	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

Reference Listed Drug

Yes

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 022468.
Type	No.	Action	Status	Date	Review
Supplement	14	Labeling	Approved	October 20, 2020	Standard
Supplement	13	Labeling	Approved	May 14, 2020	Standard
Supplement	12	Labeling	Approved	May 13, 2016	Standard
Supplement	11	Labeling	Approved	May 30, 2012	Standard
Supplement	10	Labeling	Approved	May 30, 2012	Standard
Supplement	9	Labeling	Approved	February 15, 2012	Unknown
Supplement	5	Labeling	Approved	January 7, 2011	Unknown
Supplement	4	Labeling	Approved	January 7, 2011	Unknown
Supplement	3	Labeling	Approved	January 7, 2011	Unknown
Supplement	1	Labeling	Approved	April 26, 2010	Unknown
Original application	1	Type 1 - New Molecular Entity	Approved	September 24, 2009	Priority

Review documents

0 · Supplement · October 23, 2020
0 · Supplement · October 21, 2020
0 · Supplement · May 19, 2020
0 · Supplement · May 15, 2020
0 · Supplement · May 17, 2016
0 · Supplement · May 16, 2016
0 · Supplement · June 6, 2012
0 · Supplement · June 6, 2012
0 · Supplement · June 4, 2012
0 · Supplement · June 4, 2012
0 · Supplement · February 17, 2012
0 · Supplement · February 17, 2012
0 · Supplement · January 14, 2011
0 · Supplement · January 14, 2011
0 · Supplement · January 14, 2011
0 · Supplement · January 10, 2011
0 · Supplement · January 10, 2011
0 · Supplement · January 10, 2011
0 · Supplement · April 29, 2010
0 · Supplement · April 28, 2010
0 · Original application · November 23, 2009
0 · Original application · September 29, 2009
0 · Original application · September 25, 2009

Adverse event reports

Source: openFDA FAERS

644

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PRALATREXATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
72893-003-01	72893-003	Acrotech Biopharma Inc	1 VIAL in 1 CARTON (72893-003-01) / 1 mL in 1 VIAL	September 24, 2009
72893-005-01	72893-005	Acrotech Biopharma Inc	1 VIAL in 1 CARTON (72893-005-01) / 2 mL in 1 VIAL	September 24, 2009
72893-003	72893-003	Acrotech Biopharma Inc	—	September 24, 2009
72893-005	72893-005	Acrotech Biopharma Inc	—	September 24, 2009

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.