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FDA approves add-on therapy to lower cholesterol among certain high-risk adults
… Action FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with … Drug Evaluation and Research … FDA has approved Leqvio (inclisiran) injection as a treatment to be used along with …
January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… of immune-mediated colitis. Lemtrada labeling Leqvio (inclisiran) Hypersensitivity The “Contraindications” and …
Notable Approvals | Drugs
… among certain high-risk adults 12/22/2021 Leqvio inclisiran FDA approves drug to treat, help prevent types of …
Novel Drug Approvals for 2021
… atopic dermatitis Drug Trials Snapshot 49. Leqvio inclisiran 12/22/2021 To treat heterozygous familial …
List of Pregnancy Exposure Registries
… Phone: 1-800-745-4447 (No webpage) Ongoing LEQVIO (inclisiran) Primary hypercholesterolemia Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study Phone: 1-888-669-6682 …
Drug Trials Snapshots: LEQVIO
… for additional uses of the drug (if applicable). LEQVIO (inclisiran) (leck’ vee oh) Novartis Pharmaceuticals Corp …
Table of Pharmacogenomic Biomarkers in Drug Labeling
… Studies Imipramine Psychiatry CYP2D6 Precautions Inclisiran Endocrinology Nonspecific (Heterozygous Familial …
Drug Trials Snapshots
… adults with severe alopecia areata (AA). Leqselvi LEQVIO inclisiran December 22, 2021 To treat heterozygous familial …
2021 Advancing Health Through Innovation -- New Drug Therapy Approvals
… Kerendia finerenone Korsuva difelikefalin Leqvio inclisiran Livmarli maralixibat Livtencity maribavir Lumakras … condition that causes severely high cholesterol. • Leqvio (inclisiran) [see Repatha on page 26] injection to treat …
CDER Drug and Biologic Approvals for Calendar Year 2021
… JANSSEN PHARMACEUTICALS INC P 12/20/2021 NDA 214012 LEQVIO INCLISIRAN NOVARTIS PHARMACEUTICALS CORP S 12/22/2021 NDA …
Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development
… 45 Casimersen Phosphorodiamidate morpholino ASO 22 LEQVIO Inclisiran Double-stranded siRNA 21+2 (antisense) AMVUTTRA …
CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2021
… IDENTIFICATION OF MALIGNANT LESIONS. NDA 214012 LEQVIO INCLISIRAN NOVARTIS PHARMACEUTICALS CORP S 12/22/2021 AS AN …
FY 2024 Q1 Real Time Report - Generic Drugs
… or Commitment Letter Citation (if applicable) 43 Q1 Inclisiran Sodium; Revised Draft Guidance for Industry …
OND_DTS_SummaryReport_FINAL_220422
… associated with type 2 diabetes 30 63 5 25 15 58 Leqvio Inclisiran To treat heterozygous familial hypercholester- …
wr_issued_october_2024_approved_active_moiety_10-9-241.xlsx
… Corporation 9/12/00 Imiquimod 3M Pharmaceuticals 12/28/01 Inclisiran Novartis Pharmaceuticals Corporation 11/1/19 …
Written Requests Issued
… Corporation 9/12/00 Imiquimod 3M Pharmaceuticals 12/28/01 Inclisiran Novartis Pharmaceuticals Corporation 11/1/19 …
fy_2024_q4_real_time_report_-_generic_drugs.pdf
… _050600.pdf 11/21/2023 Other N/A 43 Q1 Inclisiran Sodium; Revised Draft Guidance for Industry …
FY 2024 Q3 Real Time Report - Generic Drugs
… _050600.pdf 11/21/2023 Other N/A 43 Q1 Inclisiran Sodium; Revised Draft Guidance for Industry …
fy_2024_q2_report_shell_-_generic_drugs_508.pdf
… or Commitment Letter Citation (if applicable) 43 Q1 Inclisiran Sodium; Revised Draft Guidance for Industry …
FDA FOIA Log - November 2023
… documents regarding recent labeling updates for Leqvio (inclisiran) …