AbbVie Inc., et al.; Proposal To Withdraw Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen; Opportunity for a Hearing; Correction, 24735 [2014-09900]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2011–N–0021]
[Docket Nos. FDA–2011–E–0682; FDA–
2011–E–0683]
AbbVie Inc., et al.; Proposal To
Withdraw Approval of Abbreviated
New Drug Applications for Prescription
Pain Medications Containing More
Than 325 Milligrams of
Acetaminophen; Opportunity for a
Hearing; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 27, 2014 (79 FR
17156). The document announced an
opportunity to request a hearing on the
Agency’s proposal to withdraw approval
of abbreviated new drug applications
(ANDAs) from multiple sponsors. The
document incorrectly stated that the
approval of ANDAs 40825, 40822, and
40824, held by Ranbaxy Laboratories
Inc. and Ranbaxy Inc., 600 College Rd.
East, Princeton, NJ 08540, and ANDA
40182, held by Pharmaceutical
Associates, Inc., 201 Delaware St.,
Greenville, SC 29605, had not been
voluntarily withdrawn. FDA confirms
that the approval of ANDAs 40825,
40824, 40822, and 40182 has been
voluntarily withdrawn.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
In FR Doc.
2014–06802, appearing on page 17156,
in the Federal Register of Thursday,
March 27, 2014, the following
correction is made:
On page 17157, in table 1, the entries
for ANDAs 40825, 40824, 40822, and
40182 are removed. The approval of
these applications has been withdrawn
under 21 CFR 314.150(d).
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09900 Filed 4–30–14; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
Determination of Regulatory Review
Period for Purposes of Patent
Extension; YERVOY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
YERVOY and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human biological
product.
SUMMARY:
Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
ADDRESSES:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
24735
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product YERVOY
(ipilimumab). YERVOY is indicated for
the treatment of unresectable or
metastatic melanoma. Subsequent to
this approval, the Patent and Trademark
Office received patent term restoration
applications for YERVOY (U.S. Patent
Nos. 6,984,720 and 7,605,238) from
Medarex, Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated July 2, 2012, FDA advised
the Patent and Trademark Office that
this human biological product had
undergone a regulatory review period
and that the approval of YERVOY
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
YERVOY is 3,879 days. Of this time,
3,605 days occurred during the testing
phase of the regulatory review period,
while 274 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: August 12, 2000. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
August 12, 2000.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): June 25, 2010. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
YERVOY (BLA 125377/0) was initially
submitted on June 25, 2010.
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Page 24735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09900]
[[Page 24735]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0021]
AbbVie Inc., et al.; Proposal To Withdraw Approval of Abbreviated
New Drug Applications for Prescription Pain Medications Containing More
Than 325 Milligrams of Acetaminophen; Opportunity for a Hearing;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 27, 2014 (79 FR 17156).
The document announced an opportunity to request a hearing on the
Agency's proposal to withdraw approval of abbreviated new drug
applications (ANDAs) from multiple sponsors. The document incorrectly
stated that the approval of ANDAs 40825, 40822, and 40824, held by
Ranbaxy Laboratories Inc. and Ranbaxy Inc., 600 College Rd. East,
Princeton, NJ 08540, and ANDA 40182, held by Pharmaceutical Associates,
Inc., 201 Delaware St., Greenville, SC 29605, had not been voluntarily
withdrawn. FDA confirms that the approval of ANDAs 40825, 40824, 40822,
and 40182 has been voluntarily withdrawn.
FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.
SUPPLEMENTARY INFORMATION: In FR Doc. 2014-06802, appearing on page
17156, in the Federal Register of Thursday, March 27, 2014, the
following correction is made:
On page 17157, in table 1, the entries for ANDAs 40825, 40824,
40822, and 40182 are removed. The approval of these applications has
been withdrawn under 21 CFR 314.150(d).
Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09900 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P
