[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Page 63227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24783]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0665]
Determination That INTAL (cromolyn sodium) Inhalation Capsule, 20
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined that
INTAL (cromolyn sodium) Inhalation Capsule, 20 milligrams (mg), was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for cromolyn sodium inhalation capsule, 20 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3602.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
INTAL (cromolyn sodium) Inhalation Capsule, 20 mg, is the subject
of NDA 16-990, held by Rh[ocirc]ne-Poulenc Rorer Pharmaceuticals, Inc.,
and initially approved on June 20, 1973. INTAL is indicated for
management of patients with bronchial asthma.
In a letter dated August 16, 1999, Rh[ocirc]ne-Poulenc Rorer
Pharmaceuticals, Inc., notified FDA that INTAL (cromolyn sodium)
Inhalation Capsule, 20 mg, had been discontinued in 1995 and requested
withdrawal of NDA 16-990 for INTAL. In the Federal Register of March
20, 2000 (65 FR 14983), FDA announced that it was withdrawing approval
of NDA 16-990, effective April 19, 2000.
Alan G. Minsk and Kelley C. Nduom submitted a citizen petition
dated May 23, 2013 (Docket No. FDA-2013-P-0665), under 21 CFR 10.30,
requesting that the Agency determine whether INTAL (cromolyn sodium)
Inhalation Capsule, 20 mg, was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that INTAL (cromolyn sodium) Inhalation Capsule, 20
mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
INTAL (cromolyn sodium) Inhalation Capsule, 20 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of this product from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have found no information
that would indicate that this product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list INTAL (cromolyn
sodium) Inhalation Capsule, 20 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to INTAL (cromolyn sodium) Inhalation
Capsule, 20 mg, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: October 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24783 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P