A sold tablet is not an approval date
An offer of the tablet with no prescription, or a label PDF sitting on an unrelated site, is not an approval date. The dates in this note are the publication dates on the 1971 papers and the action dates on the FDA applications. The 2017 Vermox file on FDA's own site says, "This label may not be the latest approved by FDA."
The name was in print in 1971
The discovery a reader can date is the appearance of the name in the clinical literature. The Brugmans paper is a radiochemical and pilot clinical study in 1,278 subjects, published in JAMA on 19 July 1971. PubMed indexes it as a clinical trial. The record does not print an affiliation, a Belgian town, or the word Vermox.
The hookworm paper is the other 1971 title worth keeping. It calls the drug mebendazole (R-17,635) and "a new anthelmintic." The code is in the title. This note does not translate R-17,635 into a company, because the citation does not.
What the US file adds, three years later, is who held the first approval and where one labeled tablet was made. That is a different sentence from "the molecule was invented on a given afternoon."
28 June 1974, a 100 mg chewable from Beerse
NDA 017481 is the Vermox history that answers "when was it approved." Janssen's 100 mg chewable was approved on 28 June 1974 as a new molecular entity. The 13 June 2017 label for that application is a product of Belgium, manufactured by Janssen Pharmaceutica NV in Beerse, and manufactured for Janssen Pharmaceuticals, Inc., in Titusville, New Jersey. The tablet on that label is round, flat, radius-edged, white to yellowish, and debossed M/100 and J.
The chemical name on the later 500 mg label is methyl 5-benzoylbenzimidazole-2-carbamate. That is the same substance. The 2017 100 mg label was written for patients two years of age and older. Which worms that sentence names, and which worms the 500 mg sentence leaves off, is the mebendazole uses note. This history only needs the split in time: the 100 mg application is 1974, the 500 mg application is 2016.
Drugs@FDA now marks the 100 mg NDA product discontinued, and it records that the withdrawal was not for safety or effectiveness. Discontinued on that page is a marketing status. It does not, by itself, say a later application failed.
Do not take Emverm with metronidazole. The patient line on the current 100 mg label says serious skin reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) can happen. That warning sits on the tablet the history arrives at. It is not a footnote from 1971.
The 500 mg chewable was approved on 19 October 2016
NDA 208398 is a new formulation or a new manufacturer, not a second discovery of the molecule. Drugs@FDA's action date is 19 October 2016, with priority review and an orphan mark. DailyMed dates the marketing start one day later, 20 October 2016, and the packager on that label is Janssen Pharmaceuticals, Inc. The tablet is 500 mg, debossed M/500 and J. The highlights still say Initial U.S. Approval: 1974, which is the older clock.
The indication sentence on that label is patients one year of age and older with Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). The tablet has to be chewed completely before swallowing. How many days belong to a worm is the mebendazole 100 mg note, and the medicine page is Vermox. A 500 mg chewable is not a larger version of the 1974 household tablet.
Drugs@FDA lists this 500 mg product discontinued. The DailyMed marketing line still shows a start date and does not print an end date beside NDA 208398. A reader who needs to know whether a pharmacy can fill the 500 mg tablet has to ask the pharmacy. This history does not convert "discontinued" into a shelf count, and it does not convert a posted label into proof the tablet is stocked.
Emverm is the later 100 mg application
Emverm is mebendazole 100 mg chewable tablets from Amneal Pharmaceuticals LLC. DailyMed classifies it as an abbreviated application, ANDA 073580, with a marketing start of 15 February 2016. The marketing line does not print an end date. The imprint is ap above 107, on a round, light peach-colored tablet. The highlights carry Initial U.S. Approval: 1974, the year of the original Janssen approval, not the year Amneal's application started.
Holding an Emverm carton and calling it the Beerse M/100 tablet mixes two files that the labels themselves separate. The 2017 Janssen label names Beerse and the letters M/100 and J. The Amneal label names ap and 107. Same substance, same first-approval year on the highlights, different application and different stamp.
What the dates do not say
**When was Vermox approved in the United States?** The 100 mg chewable, NDA 017481, was approved on 28 June 1974. The 500 mg chewable, NDA 208398, was approved on 19 October 2016. Both current highlights still print Initial U.S. Approval: 1974.
**Was mebendazole discovered in 1974?** The US approval of the 100 mg chewable was 1974. The name was already the title of a JAMA paper on 19 July 1971, including a radiochemical and pilot clinical study in 1,278 subjects. The citations do not state a Belgian launch date, so this note does not add one.
**Is Emverm the tablet from Beerse?** The June 2017 Vermox label says manufactured by Janssen Pharmaceutica NV, Beerse, Belgium, and the imprint is M/100 and J. Emverm is ANDA 073580, Amneal, marketing start 15 February 2016, imprint ap above 107.
**Why does a 2016 tablet still say 1974?** Initial U.S. Approval: 1974 is the first approval of mebendazole. NDA 208398's own approval date, on Drugs@FDA, is 19 October 2016. The highlights line and the application date are two different clocks.