[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52182-52183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-0038]


Determination That CUBICIN (Daptomycin) Powder for Injection, 250 
Milligrams/Vial and 500 Milligrams/Vial, and CUBICIN RF (Daptomycin) 
Powder for Injection, 500 Milligrams/Vial, Were Not Withdrawn From Sale 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 or Agency) has 
determined that CUBICIN (daptomycin) Powder for Injection, 250 
milligrams (mg)/vial and 500 mg/vial, and CUBICIN RF (daptomycin) 
Powder for Injection, 500 mg/vial, were not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for daptomycin 
powder for injection, 250 mg/vial and 500 mg/vial, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Tereza Hess, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 202-
768-5659, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved, and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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.
    CUBICIN (daptomycin) Powder for Injection, 250 mg/vial and 500 mg/
vial, initially approved on September 12, 2003, and CUBICIN RF 
(daptomycin) Powder for Injection, 500 mg/vial, initially approved on 
July 6, 2016, are the subjects of NDA 021572, held by Cubist 
Pharmaceuticals, LLC. CUBICIN and CUBICIN RF are indicated for 
treatment of complicated skin and skin structure infections in adult 
and pediatric patients (1 to 17 years of age), and Staphylococcus 
aureus bloodstream infections (bacteremia) in adult patients including 
those with right-sided infective endocarditis. CUBICIN is also 
indicated for treatment of S. aureus bloodstream infections 
(bacteremia) in pediatric patients (1 to 17 years of age).
    CUBICIN (daptomycin) Powder for Injection, 250 mg/vial is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book. In a letter dated June 22, 2021, Cubist Pharmaceuticals, LLC 
notified FDA that CUBICIN RF (daptomycin) Powder for Injection, 500 mg/
vial was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book. In a 
letter dated March 30, 2022, Cubist Pharmaceuticals, LLC notified FDA 
that CUBICIN (daptomycin) Powder for Injection, 500 mg/vial was being 
discontinued, and FDA moved the drug product to the ``Discontinued Drug 
Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition 
dated January 3, 2023 (Docket No. FDA-2023-P-0038), under 21 CFR 10.30, 
requesting that the Agency determine whether CUBICIN RF (daptomycin) 
Powder for Injection, 500 mg/vial, was withdrawn from sale for reasons 
of safety or effectiveness. Although the citizen petition did not 
address the CUBICIN (daptomycin) Powder for Injection, 250 mg/vial and 
500 mg/vial

[[Page 52183]]

strengths, these strengths have also been discontinued. On our own 
initiative, we have also determined whether these strengths were 
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 CUBICIN (daptomycin) Powder for Injection, 250 
mg/vial and 500 mg/vial, and CUBICIN RF (daptomycin) Powder for 
Injection, 500 mg/vial, were not withdrawn from sale for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that these drug products were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of CUBICIN (daptomycin) 
Powder for Injection, 250 mg/vial and 500 mg/vial, and CUBICIN RF 
(daptomycin) Powder for Injection, 500 mg/vial, 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 these drug products were withdrawn from sale for reasons 
of safety or effectiveness.
    Accordingly, the Agency will continue to list CUBICIN (daptomycin) 
Powder for Injection, 250 mg/vial and 500 mg/vial, and CUBICIN RF 
(daptomycin) Powder for Injection, 500 mg/vial, 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 these drug products 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 these drug products should be revised to meet current standards, 
the Agency will advise ANDA applicants to submit such labeling.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16775 Filed 8-4-23; 8:45 am]
BILLING CODE 4164-01-P