[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18352-18353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-0649]


Determination That QUESTRAN (Cholestyramine for Oral Suspension, 
USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for 
Oral Suspension, USP), Equivalent to 4 Grams, Were Not Withdrawn From 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 
QUESTRAN (cholestyramine for oral suspension, USP), equivalent to (EQ) 
4 grams (g), and QUESTRAN LIGHT (cholestyramine for oral suspension, 
USP), EQ 4 g, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination means that FDA will not begin 
procedures to withdraw approval of the abbreviated new drug 
applications (ANDAs) that refer to these drugs, and it will allow FDA 
to approve ANDAs that refer to these drugs as long as they meet 
relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Carolina M. Wirth, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6282, 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)

[[Page 18353]]

(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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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.
    QUESTRAN (cholestyramine for oral suspension, USP), EQ 4 g, is the 
subject of NDA 16-640, held by Bristol-Myers Squibb, and initially 
approved on August 3, 1973. QUESTRAN LIGHT (cholestyramine for oral 
suspension, USP), EQ 4 g, is the subject of NDA 19-669, also held by 
Bristol-Myers Squibb, and initially approved on December 5, 1988. 
QUESTRAN and QUESTRAN LIGHT are indicated as adjunctive therapy for the 
reduction of elevated serum cholesterol in patients with primary 
hypercholesterolemia (elevated low-density lipoprotein cholesterol) who 
do not respond adequately to diet.
    In a letter dated May 31, 2012, Bristol-Myers Squibb notified FDA 
that QUESTRAN (cholestyramine for oral suspension, USP), EQ 4 g, and 
QUESTRAN LIGHT (cholestyramine for oral suspension, USP), EQ 4 g, were 
being discontinued, and FDA moved the drug products to the 
``Discontinued Drug Product List'' section of the Orange Book. Lachman 
Consultant Services, Inc., submitted a citizen petition dated June 19, 
2012 (Docket No. FDA-2012-P-0649), under 21 CFR 10.30, requesting that 
the Agency determine whether QUESTRAN (cholestyramine for oral 
suspension, USP), EQ 4 g, was withdrawn from sale for reasons of safety 
or effectiveness. Although the citizen petition did not address 
QUESTRAN LIGHT, that version of the drug product has also been 
discontinued. On our own initiative, we have also determined whether 
QUESTRAN LIGHT was withdrawn for safety or effectiveness reasons.
    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 QUESTRAN (cholestyramine for oral suspension, 
USP), EQ 4 g, and QUESTRAN LIGHT (cholestyramine for oral suspension, 
USP), EQ 4 g, were not withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of QUESTRAN (cholestyramine for oral 
suspension, USP), EQ 4 g, and QUESTRAN LIGHT (cholestyramine for oral 
suspension, USP), EQ 4 g, 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 
either product was withdrawn from sale for reasons of safety or 
effectiveness. Moreover, the petitioner has identified no data or other 
information suggesting that QUESTRAN (cholestyramine for oral 
suspension, USP), EQ 4 g, was withdrawn for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list QUESTRAN 
(cholestyramine for oral suspension, USP), EQ 4 g, and QUESTRAN LIGHT 
(cholestyramine for oral suspension, USP), EQ 4 g, 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. FDA will not begin procedures to withdraw 
approval of the approved ANDAs that refer to QUESTRAN or QUESTRAN 
LIGHT. Additional ANDAs for cholestyramine and cholestyramine light for 
oral suspension, USP, EQ 4 g, may also 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 these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06825 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P