[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]


-----------------------------------------------------------------------

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Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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.

-----------------------------------------------------------------------

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withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of safety or effectiveness (21 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