[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31790-31791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0278]


Determination That Cysteine Hydrochloride Injection, USP, 7.25%, 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its 
determination that Cysteine Hydrochloride Injection, USP, 7.25% 
(Cysteine HCl), was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for Cysteine HCl if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6358, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved 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.

[[Page 31791]]

Sponsors of ANDAs 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 
(Sec.  314.162 (21 CFR 314.162)). Under Sec.  314.161(a)(1) (21 CFR 
314.161(a)(1)), the agency must determine whether a listed drug was 
withdrawn from sale for reasons of safety or effectiveness before an 
ANDA that refers to that listed drug may be approved. FDA may not 
approve an ANDA that does not refer to a listed drug.
    Cysteine HCl is the subject of NDA 19-523, most recently held by 
Hospira, Inc. (Hospira), and initially approved on October 22, 1986. 
Cysteine HCl is indicated for use as an additive to amino acid 
solutions to meet the nutritional requirements of newborn infants 
requiring total parenteral nutrition (TPN) and of adult and pediatric 
patients with severe liver disease who may have impaired enzymatic 
processes and require TPN. It can also be added to amino acid solutions 
to provide a more complete profile of amino acids for protein 
synthesis. Hospira notified FDA in a letter dated May 26, 2005, that it 
had not commercially manufactured and marketed Cysteine HCl, and 
voluntarily asked that the NDA be withdrawn. The drug product was moved 
to the ``Discontinued Drug Product List'' section of the Orange Book, 
and FDA withdrew approval of NDA 19-523 effective June 16, 2006 (71 FR 
34940). In previous instances (see, e.g., 74 FR 63404, December 3, 
2009; 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the agency 
has determined that, for purposes of Sec. Sec.  314.161 and 314.162, 
never marketing an approved drug product is equivalent to withdrawing 
the drug from sale. Regulus Pharmaceutical Consulting, Inc., submitted 
a citizen petition, dated April 30, 2008 (Docket No. FDA-2008-P-0278), 
under 21 CFR 10.30, requesting that the agency determine whether 
Cysteine HCl was withdrawn from sale for reasons of safety or 
effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that Cysteine Hydrochloride Injection, USP, 7.25%, was not 
withdrawn for reasons of safety or effectiveness. We have also 
independently evaluated relevant literature and have found no 
information that would indicate that this product was withheld from 
sale for reasons of safety or effectiveness. Accordingly, the agency 
will continue to list Cysteine Hydrochloride Injection, USP, 7.25%, 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 Cysteine 
Hydrochloride Injection, USP, 7.25% may be approved by the agency if 
all other legal and regulatory requirements for the approval of ANDAs 
are met. If FDA determines that the labeling for this drug product 
should be revised to meet current standards, the agency will advise 
ANDA applicants to submit such labeling.

    Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13463 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S