Notice2023-16775
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and 500 Milligrams/Vial, and CUBICIN RF (Daptomycin) Powder for Injection, 500 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 7, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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250 milligrams (mg)/vial and 500 mg/vial, and CUBICIN RF (daptomycin) Powder for Injection, 500 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 150 (Monday, August 7, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52182-52183]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16775]
-----------------------------------------------------------------------
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Powder for Injection, 500 Milligrams/Vial, Were Not Withdrawn From Sale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.
-----------------------------------------------------------------------
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Powder for Injection, 500 mg/vial, were not withdrawn from sale for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, <a href="/cdn-cgi/l/email-protection#7e0a1b0c1b041f50161b0d0d3e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="c6b2a3b4a3bca7e8aea3b5b586a0a2a7e8aeaeb5e8a1a9b0">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 7, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.