Exhibit 14 (FDA Ivermectin Approval Package) — Apter v. HHS

Record facts

U.S. District Court for the Southern District of Texas (Galveston Division) · No. 3:22-cv-00184 · Doc. 12-14 · 2022-08-08 · Docket on CourtListener

Full text

Exhibit 14
Case 3:22-cv-00184   Document 12-14   Filed on 08/08/22 in TXSD   Page 1 of 4

CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVAL PACKAGE for:
APPLICATION NUMBER:    050742         
TRADE NAME:   Mectizan     
GENERIC NAME:        Ivermectin  
SPONSOR: Merck Research Laboratories          
APPROVAL DATE: 11/22/96 
Case 3:22-cv-00184   Document 12-14   Filed on 08/08/22 in TXSD   Page 2 of 4

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DEPARTMENT
OF HEALTH
& HUMAN
SERVICES
:
Public
Heaw
Sewice
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Food and Drug Administration
Rockville
MD
20W7
.
NDA 50-742
Kenneth R. Brown, M.D.
Exetxtive
Director
Worldwide Regulatory
Liaison
Biologics/Vaccines
Merck & Co., Inc
West Poin~ PA 19486-0004
NOV22
19%
Dear Dr. Brown:
Reference is made to your March
29, 1996 new drug application
(NDA) and your resubmission
dated October 15, 1996, submitted under section 507 of the Federal Food, Drug, and Cosmetic
Act
for Tablet STROMECTOL@
(ivexmectin) 6-mg.
We acknowledge receipt of your amendments
dated April 16, June 28, July 9,
16, 22,
and 31,
August 23, and 28, and October 4, 1996.
This new drug application
provides
for the treatment
of strongyloidiasis
and onchocerciasis.
We have completed the review of this application,
including the submitted draft labeling, and have
concluded
that adequate
information
has been presented
to demonstrate
that the drug product
is
safe and effective
for use as recommended
in the enclosed
draft
labeling.
Accordingly,
the
application
is approved
effective
on the date of this letter.
The fml
printed labeling (FPL) must be identical to the enclosed draft labeling.
Marketing
the
product with FPL that is not identical to this draft labeling may render the product misbranded
and
an unapproved
new drug.
Please submit sixteen copies of the FPL as soon as it is available,
in no case more than 30 days
after it is printed.
Please individually
mount ten of the copies on heavy weight paper or similar
material.
For administrative
purposes
this submission
should be desigmted
“FINAL
P~TED
LABELING”
for approved
NDA 50-742.
Approval
of this submission
by FDA is not required
before the labeling is used.
..
Should additional information
relating to the safety and effectiveness of the drug become available,
revision of that labeling may be required.
In addition, please submit three copies of the introductory
promotional
material
that you propose
to use for this product.
All proposed
materials should be submitted in draft or mock-up form, not
final print.
Please submit one copy to the Division of Anti-Infective
Drug Products and two copies
of both the promotioml
material
and the package insert directly to:
Case 3:22-cv-00184   Document 12-14   Filed on 08/08/22 in TXSD   Page 3 of 4

Page
2
.
Food and Drug Administration
Division
of Drug
Marketing,
Advertising
and Communications,
HFD-40
5600 Fishers
Lane
Rockville,
Maryland
20857
Validation of the regulatory
methods has not been completed.
At the present time, it is the policy
of the Center not to withhold
approval
because the methods are being validated.
Nevertheless,
we expect your continued
cooperation
to resolve any problems
that may be identified.
Please submit one market package of the drug when it is available.
We remind you that you must comply with the requirements
for an approved NDA set forth under
21 CFR 314.80 and 314.81.
If you have any questions,
please
contact:
Ms. Pauline
Fogarty
Regulatory
Health
Project
Manager
(301)
827-2125
Sincerely
yours,
-.
.-
w~fq—?
David
W. Feigal,
Jr.,
.D., M.P.H.
Acting
Director
OffIce of Drug Evaluation
IV
Center
for Drug Evaluation
and Research
ENCLOSURE
,“
Case 3:22-cv-00184   Document 12-14   Filed on 08/08/22 in TXSD   Page 4 of 4

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