SILVER
SPRING, Md., April 26,
2024 /PRNewswire/ -- Today, the U.S. Food and
Drug Administration is providing an at-a-glance summary of news
from around the agency:
- Today, the FDA published the FDA Voices: "A Milestone in
Facilitating the Development of Safe and Effective Biosimilars," by
Sarah Yim, Director of the Office of
New Drugs' Office of Therapeutic Biologics and Biosimilars,
Hilary Marston, M.D., M.P.H., and
Patrizia Cavazzoni, M.D., Director,
Center for Drug Evaluation and Research. This week, the FDA
approved the 50th biosimilar, reflecting the markedly increased
availability of biosimilar products—products that treat a wide
range of chronic and severe illnesses, and which have already had
an important impact on patient access. Biosimilars are now approved
for 15 different reference biologics, and treat illnesses like
rheumatoid arthritis, inflammatory bowel disease, some cancers,
psoriasis, diabetes, macular degeneration, osteoporosis, and more.
The agency has also updated and re-released the Biosimilars Action
Plan to reinforce the FDA's commitment to these important
initiatives and to articulate a strategy to further expand
biosimilar product availability and utilization.
- Today, the FDA announced that is has finalized Guidance
for Industry (GFI) #120: Veterinary Feed Directive Regulation
Questions and Answers, to provide guidance to industry on the
requirements of the veterinary feed regulations (i.e., the
Veterinary Feed Directive (VFD) final rule) . The VFD final rule
outlines the process for authorizing the use of approved animal
drugs intended for use in or on the feed of food-producing animals
that require veterinary oversight, including medically important
antimicrobials when needed for specific animal health purposes.
This final guidance also serves as a Small Entity Compliance
Guide.
- On Thursday, the FDA announced it has approved the first
generic pimobendan for the management of congestive heart failure
in dogs. Pimomedin (pimobendan) chewable tablets is approved for
the management of the signs of mild, moderate, or severe congestive
heart failure in dogs due to clinical myxomatous mitral valve
disease (MMVD) or dilated cardiomyopathy (DCM). Pimomedin is
indicated for use with concurrent therapy for congestive heart
failure (e.g., furosemide, etc.) as appropriate on a case-by-case
basis. Pimomedin is only available by prescription from a licensed
veterinarian.
- On Wednesday, the FDA issued an additional warning letter
that describes violations related to the sale and distribution of
unauthorized plastic syringes made in China that have not been cleared or approved
by the FDA for sale or distribution in the U.S. The warning letter
issued to Cardinal Health (firm marketing and distributing plastic
syringes made in China within the
U.S.) also describes violations related to quality system
regulations for syringe products. The FDA expects this firm to
fully address the violations described in the warning letter. The
FDA will continue efforts to evaluate problems with syringes made
in China and keep the public
informed as new or additional information becomes available.
- On Tuesday, the FDA posted the Report on the
Performance of Drugs and Biologics Firms in Conducting
Postmarketing Requirements and Commitments (PMCs) for FY
2022. The FDA is pleased to report that applicants
successfully completed (fulfilled) or released most of the
Postmarketing Requirements (PMRs)/Postmarketing Commitments (PMCs)
for the previous years reported on in the FY 2022 report. The
majority of PMRs/PMCs are progressing according to the original
schedule. Overall, few PMRs/PMCs are delayed. The FDA is committed
to ensuring that PMRs and PMCs, which further describe the safety,
efficacy, and/or optimal use of a drug, are conducted and reported
as required.
- On Tuesday, the FDA approved lutetium Lu 177 dotatate
(Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric
patients 12 years and older with somatostatin receptor
(SSTR)-positive gastroenteropancreatic neuroendocrine tumors
(GEP-NETs), including foregut, midgut, and hindgut neuroendocrine
tumors. Lutetium Lu 177 dotatate received approval for this
indication for adults in 2018. This represents the first FDA
approval of a radioactive drug, or radiopharmaceutical, for
pediatric patients 12 years of age and older with SSTR-positive
GEP-NETs. Full prescribing information for Lutathera will be posted
here.
- On Tuesday, the FDA granted accelerated approval to
tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients
6 months of age and older with relapsed or refractory pediatric
low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or
BRAF V600 mutation. This represents the first FDA approval of a
systemic therapy for the treatment of patients with pediatric LGG
with BRAF rearrangements, including fusions. Full prescribing
information for Ojemda will be posted here.
Additional Resources:
# # #
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration