[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12310-12311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1978-N-0441] (formerly 78N-0324); DESI 10392]


Drugs for Human Use; Drug Efficacy Study Implementation; 
Prescription Drugs That Contained Hydroxyzine Hydrochloride or 
Hydroxyzine Pamoate; Final Resolution of Docket

ACTION: Notice; withdrawal of a hearing request.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that all 
outstanding hearing requests pertaining to Docket FDA-1978-N-0441 
(formerly 78N-0324) have been withdrawn. Therefore, shipment in 
interstate commerce of any of the products identified in that docket, 
or any identical, related, or similar (IRS) product that is not the 
subject of an approved new drug application (NDA) or abbreviated new 
drug application (ANDA) (other than an over-the-counter (OTC) product 
that complies with an applicable OTC monograph), is unlawful as of the 
effective date of this notice.

DATES: Effective Date: This notice is effective February 29, 2012.

ADDRESSES: All communications in response to this notice should be 
identified with the docket number found in brackets in the heading of 
this document, and directed to Pamela Lee, Office of Unapproved Drugs 
and Labeling Compliance, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5173, 
Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Pamela Lee, Office of Unapproved Drugs 
and Labeling Compliance, Office of Compliance, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5173, Silver Spring, MD 20993-0002, 301-
796-3297, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    When initially enacted in 1938, the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) required that ``new drugs'' be approved for 
safety by FDA before they could legally be sold in interstate 
commerce.\1\ To this end, the FD&C Act made it the sponsor's 
responsibility, before marketing a new drug, to submit an NDA to FDA to 
prove that its drug was safe. Between 1938 and 1962, if a drug obtained 
approval, FDA considered drugs that were IRS \2\ to the approved drug 
to be ``covered'' by that approval, and allowed those IRS drugs to be 
marketed without independent approval.
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    \1\ A ``new drug'' is defined by the FD&C Act as a drug that 
``is not generally recognized, among experts qualified by scientific 
training and experience to evaluate the safety and effectiveness of 
drugs, as safe and effective for use under the conditions 
prescribed, recommended, or suggested in the labeling thereof, 
except that such a drug not so recognized shall not be deemed to be 
a `new drug' if at any time prior to the enactment of this Act it 
was subject to the Food and Drugs Act of June 30, 1906, as amended, 
and if at such time its labeling contained the same representations 
concerning the conditions of its use * * *.'' (21 U.S.C. 321(p)).
    \2\ Section 310.6(b)(1) ((21 CFR 310.6(b)(1)) provides: ``An 
identical, related, or similar drug includes other brands, 
potencies, dosage forms, salts, and esters of the same drug moiety 
as well as of any drug moiety related in chemical structure or known 
pharmacological properties.''
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    In 1962, Congress amended the FD&C Act to require that new drugs be 
proven effective for their labeled indications, as well as safe, to 
obtain FDA approval. This amendment also caused FDA to conduct a 
retrospective evaluation of the effectiveness of the drug products that 
FDA had approved as safe between 1938 and 1962. FDA contracted with the 
National Academy of Sciences/National Research Council (NAS/NRC) to 
make an initial evaluation of the effectiveness of over 3,400 products 
that had been approved only for safety between 1938 and 1962. The NAS/
NRC reports for these drug products were submitted to FDA in the late 
1960s and early 1970s. The Agency reviewed and re-evaluated the reports 
and published its findings in Federal Register notices. FDA's 
administrative implementation of the NAS/NRC reports was called the 
Drug Efficacy Study Implementation (DESI). DESI covered the 
approximately 3,400 products specifically reviewed by the NAS/NRC, as 
well as the even larger number of IRS products that entered the market 
without FDA approval.
    All drugs covered by the DESI review are ``new drugs'' under the 
FD&C Act. If FDA's final DESI determination classifies a drug product 
as lacking substantial evidence of effectiveness for one or more 
indications, that drug product and those IRS to it may no longer be 
marketed for the indications and are subject to enforcement action as 
unapproved new drugs. If FDA's final DESI determination classifies the 
drug product as effective for one or more of its labeled indications, 
the drug can be marketed for those indications, provided it is the 
subject of an application approved for safety and effectiveness. 
Sponsors of drug products that have been found to be effective for one 
or more indications through the DESI process may rely on FDA's 
effectiveness determinations, but typically must update their labeling 
to conform to the indication(s) found to be effective by FDA and 
include any additional safety information required by FDA. Those drug 
products with NDAs approved before 1962 for safety therefore require 
approved supplements to their original applications if one or more 
indications are found to be effective under DESI; IRS drug products 
require an approved NDA or ANDA, as appropriate. Furthermore, labeling 
for drug products classified as effective may contain only those 
indications for which the review found the product effective, unless 
the firm marketing the product has received an approval for the 
additional indication(s).

II. Docket No. FDA-1978-N-0441 (formerly 78N-0324); DESI 10392

    Under Docket No. FDA-1978-N-0441 (formerly 78N-0324), FDA evaluated 
the evidence of effectiveness for various indications for Atarax 
Tablets (NDA 10-392), Atarax Syrup (NDA 10-485), Vistaril Injection 
(NDA 11-111), Vistaril Capsules (NDA 11-459), and Vistaril Oral 
Suspension (NDA 11-795), products owned by Pfizer, Inc. (Pfizer),

[[Page 12311]]

and B. Roerig & Co., then a division of Pfizer, that contained 
hydroxyzine hydrochloride and hydroxyzine pamoate (44 FR 6780, February 
2, 1979) (the February 1979 Federal Register notice). Although some 
indications for these products were found to be supported by adequate 
and well-controlled clinical studies, other indications were determined 
to be lacking substantial evidence of effectiveness (Id.). The February 
1979 Federal Register notice offered an opportunity for hearing with 
respect to the indications found to be lacking substantial evidence of 
effectiveness, as well as with respect to any issues relating to the 
legal status of the drug products subject to it.
    In response to the February 1979 Federal Register notice, Pfizer 
requested a hearing. No other companies requested a hearing. On 
November 22, 2010, FDA sent a letter to Pfizer to determine whether 
Pfizer remained interested in pursuing its hearing request. On December 
22, 2010, Pfizer responded by withdrawing its hearing request. There 
are no longer outstanding hearing requests pertaining to Docket No. 
FDA-1978-N-0441 (formerly 78N-0324). Therefore, shipment in interstate 
commerce of any product identified in this docket, or any IRS product, 
that is not the subject of an approved NDA or ANDA is unlawful as of 
the effective date of this notice. This notice is not applicable to OTC 
products that comply with an OTC monograph (21 CFR 310.6(f)). Any 
person who wishes to determine whether a specific product is covered by 
this notice should write to the Center for Drug Evaluation and Research 
(see ADDRESSES).

III. Discontinued Products

    Some firms may have previously discontinued the manufacturing or 
distribution of products covered by this notice without removing them 
from the listing of their products under section 510(j) of the FD&C Act 
(21 U.S.C. 360(j)). Other firms may discontinue manufacturing or 
marketing listed products in response to this notice. Firms that wish 
to notify the Agency of product discontinuation should send a letter, 
signed by the firm's chief executive officer, fully identifying the 
discontinued product(s), including National Drug Code (NDC) number(s), 
and stating that the product(s) have been discontinued. The letter 
should be sent to Pamela Lee (see ADDRESSES).
    Firms should also update the listing of their products under 
section 510(j) of the FD&C Act to reflect discontinuation of unapproved 
products. FDA plans to rely on its existing records, including drug 
listing records or other available information, when it targets 
violations for enforcement action. Firms should be aware that after the 
effective date of this notice, FDA intends to take enforcement action 
without further notice against any firm that manufactures or ships in 
interstate commerce any unapproved product covered by this notice.

IV. Reformulated Products

    FDA cautions firms against reformulating products into OTC products 
or different unapproved new drugs that are marketed under the same name 
or substantially the same name (including a new name that contains the 
old name). Reformulated products marketed under a name previously 
identified with a different active ingredient or combination of active 
ingredients have the potential to confuse health care practitioners and 
harm patients.
    This notice is issued under the FD&C Act (sections 502 and 505 (21 
U.S.C. 352 and 355)), and under authority delegated to the Deputy 
Commissioner for Policy under section 1410.10 of the FDA Staff Manual 
Guide.

    Dated: February 17, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-4781 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P