>>14485292
NDA 50-742/S-024
NDA 50-742/S-025
Merck and Co., Inc.
Attention: Peter Kusma
Manager, Regulatory Affairs
P. O. Box 1000, UG2CD-48
North Wales, PA 19454-1099
Dear Mr. Kusma:
Please refer to your supplemental new drug applications submitted under section 505(b) of the Federal
Food, Drug, and Cosmetic Act for Stromectol™ (ivermectin), Tablets 3 mg as follows:
We acknowledge receipt of your submissions dated December 17, 2008 and April 22, 2009 for
NDA 50-742/S-024 and April 1, 2009 for NDA 50-742/S-025. Your submissions dated April 1, 2009
contained the final printed labeling for both supplements S-024 and S-025.
These “Changes Being Effected” supplemental new drug applications provide for revisions to the
formatting of the ADVERSE REACTIONS/Post-Marketing experience subsection of the package
insert and addition of Onchocerciasis/conjunctival hemorrhage (S-024) and addition of hepatitis (S025) to the same subsection of the package insert as follows (underlined text = addition, strikethrough
text = deletion):
The ADVERSE REACTIONS/Post-Marketing experience subsection is revised as follows:
Post-Marketing Experience
The following adverse reactions have been reported since the drug was registered overseas:
Onchocerciasis
Conjunctival hemorrhage
Post-Marketing Experience forAll Indications
The following adverse reactions have been reported since the drug was registered
overseas:Hhypotension (mainly orthostatic hypotension), worsening of bronchial asthma,
toxic epidermal necrolysis, Stevens-Johnson syndrome, seizures, hepatitis, elevation of liver
enzymes, and elevation of bilirubin.
We completed our review of these applications, as amended. These applications are approved,
effective on the date of this letter, for use as recommended in the agreed-upon labeling text for the
package insert submitted on April 1, 2009.
If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
the following address:
MEDWATCH
Food and Drug Administration
Suite 12B05
5600 Fishers Lane
Rockville, MD 20857
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Judit Milstein, Regulatory Project Manager, at (301) 796-1600.
Sincerely,
{See appended electronic signature page}
Ozlem Belen, M.D., MPH
Deputy Director for Safety
Division of Special Pathogen and Transplant
Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research
Link for above
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf
NDA 50-742/S-024 and S-025
Page 3
TABLETS
STROMECTOL®
(IVERMECTIN)
INDICATIONS AND USAGE
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL is indicated for the treatment of intestinal (i.e.,
nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of
infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL
PHARMACOLOGY, Clinical Studies.)
Onchocerciasis. STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode
parasite Onchocerca volvulus.
This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted
in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used
diethylcarbamazine citrate (DEC-C).
NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites. The adult parasites
reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules
(nodulectomy) may be considered in the management of patients with onchocerciasis, since this procedure will
eliminate the microfilariae-producing adult parasites
Link to above
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf