Final-year regulatory record · CDER novel approvals · verified 29 Oct 2026
FDA Novel Drug Approvals 2025: All 46 Drugs and Key Insights
FDA novel drug approvals in 2025 closed at 46 — new molecular entities and new therapeutic biologics approved by FDA’s Center for Drug Evaluation and Research (CDER) between 17 January and 30 December 2025.[1] That is four fewer than 2024’s 50. 20 were first-in-class, 23 carried orphan designation and 33 used at least one expedited programme, according to CDER’s year-end report.[2]
The year is closed, so this list is final. Every row below is checked against FDA’s own 2025 page and CDER’s January 2026 report; the “approved use” text is a summary and the current prescribing information on Drugs@FDA governs.
Distribution
CDER also reports that 32 of the 46 (70%) were approved in the US before any other country, and 39 (85%) were approved on the first review cycle.[2]
The shape of 2025
Approvals by month
- Q1 7
- Q2 9
- Q3 16
- Q4 14
The second half carried two-thirds of the year: 16 approvals in Q3 and 14 in Q4, with 7 in December alone.[1]
By therapeutic area
FDA does not publish area counts. This is Laafon’s grouping by approved use; oncology includes the tenosynovial giant cell tumour, NF1 plexiform neurofibroma and transplant-conditioning approvals.
By modality
- Small molecule 30
- Biologic (BLA) 12
- Oligonucleotide 3
- Peptide 1
Classified by molecule type from published mechanism data.[3] Biologics here means products licensed as BLAs (antibodies, antibody-drug conjugates, a fusion protein); the three oligonucleotides and the peptide were NDAs.
2025 against the previous four years
CDER novel approvals: 50, 37, 55, 50 and 46.[4] 2025 sits close to the recent average, not a collapse.
What stood out
Non-opioid pain · 30 Jan
Journavx (suzetrigine), a NaV1.8 inhibitor, was approved for moderate-to-severe acute pain and carried four flags: first-in-class, Fast Track, Breakthrough and Priority Review.
Two new antibacterials
Blujepa (gepotidacin, uncomplicated UTI, March) and Nuzolvence (zoliflodacin, gonorrhoea, December) were both counted first-in-class by CDER.
Hereditary angioedema × 3
Andembry and Dawnzera for prevention, Ekterly as an oral on-demand option — three HAE approvals in one year.
HER2-mutant lung cancer × 2
Hernexeos (August) and Hyrnuo (November), both oral HER2 TKIs under accelerated approval, for NSCLC with HER2 tyrosine kinase domain mutations.
What FDA’s 2025 novel drug list omits
FDA’s list counts only CDER products whose active ingredient had never been approved in the US. Four groups of 2025 approvals are therefore not in the 46:
- CBER cell and gene therapies. Products such as revakinagene taroretcel-lwey, prademagene zamikeracel, zopapogene imadenovec-drba and etuvetidigene autotemcel were licensed by FDA’s biologics centre, not CDER.[3]
- Vaccines, blood products and allergenics — also CBER.
- Biosimilars and interchangeables — they rely on an already-licensed reference product, so they are not novel.
- New salts, esters, combinations and dosage forms of previously approved actives. Subcutaneous Keytruda Qlex appears on the list because its co-formulated enzyme, berahyaluronidase alfa, had not been approved before; pembrolizumab itself had.
What changed in this revision (29 Oct 2026)
- Two approval dates corrected. Kygevvi was listed as 11 March 2025; FDA lists 3 November 2025. Jascayd was listed as 10 July 2025; FDA lists 7 October 2025. Both were US-format dates read the wrong way round.
- Brand and ingredient spellings corrected to FDA’s list: Lynkuet (elinzanetant), Rhapsido, Hyrnuo, Komzifti, Modeyso, Ibtrozi, Emrelis, Gomekli.
- Summary figures replaced with CDER’s own counts. Orphan was given as “10–15” (actual 23); expedited as “16–20” (actual 33); first-in-class as “4–7” (actual 20). Biologics corrected from 15 to 12 BLA products.
- Designations completed for all 46 rows from CDER’s report. Voyxact had been marked orphan; it is not on CDER’s orphan list.
- Definition corrected. A novel drug is one whose active ingredient was never before approved in the US; a unique mechanism is not required.
- Sponsor, mechanism class and sources added; every 2025 drug with a full Laafon analysis (33 of 46) is now linked from the table; the unsupported “FDA changes in 2025” FAQ removed.
All 46 FDA novel drug approvals of 2025, January to December
Showing 46 of 46 approvals
Scroll the table sideways →
| Active ingredient | Modality | Designations | FDA-approved use on approval date | |||||
|---|---|---|---|---|---|---|---|---|
| 1 | Datroway | datopotamab deruxtecan-dlnk | 17 Jan 2025 | AstraZeneca / Daiichi Sankyo | Oncology | Biologic (BLA)TROP2-directed antibody-drug conjugate | None | Unresectable or metastatic HR-positive, HER2-negative breast cancer after endocrine therapy and chemotherapy |
| 2 | Grafapex | treosulfan | 21 Jan 2025 | Medexus Pharmaceuticals | Oncology | Small moleculeAlkylating agent (conditioning regimen) | Orphan | With fludarabine, preparative regimen before allogeneic stem cell transplant in AML and MDS |
| 3 | Journavx | suzetrigine | 30 Jan 2025 | Vertex Pharmaceuticals | Neurology / pain | Small moleculeNaV1.8 sodium channel inhibitor (non-opioid) | First-in-classFast TrackBreakthroughPriority Review | Moderate-to-severe acute pain in adults |
| 4 | Gomekli | mirdametinib | 11 Feb 2025 | SpringWorks Therapeutics | Oncology | Small moleculeMEK1/2 inhibitor | OrphanFast TrackPriority Review | Neurofibromatosis type 1 with symptomatic plexiform neurofibromas not amenable to complete resection |
| 5 | Romvimza | vimseltinib | 14 Feb 2025 | Deciphera Pharmaceuticals | Oncology | Small moleculeCSF1R kinase inhibitor | Fast TrackPriority Review | Symptomatic tenosynovial giant cell tumour where surgery risks worsening function or severe morbidity |
| 6 | Blujepa | gepotidacin | 25 Mar 2025 | GSK | Infectious disease | Small moleculeBacterial type II topoisomerase inhibitor | First-in-classPriority Review | Uncomplicated urinary tract infections |
| 7 | Qfitlia | fitusiran | 28 Mar 2025 | Sanofi | Hematology | OligonucleotideAntithrombin-lowering siRNA | First-in-classOrphanFast Track | Routine prophylaxis of bleeding episodes in haemophilia A or B, with or without inhibitors |
| 8 | Vanrafia | atrasentan | 2 Apr 2025 | Novartis | Nephrology | Small moleculeEndothelin A receptor antagonist | Accelerated Approval | Reducing proteinuria in primary IgA nephropathy at risk of rapid progression |
| 9 | penpulimab-kcqx | penpulimab-kcqx | 23 Apr 2025 | Akeso | Oncology | Biologic (BLA)Anti-PD-1 monoclonal antibody | OrphanFast TrackBreakthrough | Recurrent or metastatic non-keratinising nasopharyngeal carcinoma |
| 10 | Imaavy | nipocalimab-aahu | 29 Apr 2025 | Johnson and Johnson | Neurology / pain | Biologic (BLA)Anti-FcRn monoclonal antibody | OrphanFast TrackPriority Review | Generalised myasthenia gravis |
| 11 | Avmapki Fakzynja Co-Pack | avutometinib and defactinib | 8 May 2025 | Verastem Oncology | Oncology | Small moleculeRAF/MEK clamp + FAK inhibitor (co-pack) | First-in-classOrphanBreakthroughPriority ReviewAccelerated Approval | KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy |
| 12 | Emrelis | telisotuzumab vedotin-tllv | 14 May 2025 | AbbVie | Oncology | Biologic (BLA)c-Met-directed antibody-drug conjugate | First-in-classBreakthroughPriority ReviewAccelerated Approval | Advanced non-squamous NSCLC with high c-Met protein overexpression, after prior systemic therapy |
| 13 | Tryptyr | acoltremon | 28 May 2025 | Alcon | Ophthalmology | Small moleculeTRPM8 agonist eye drop | First-in-class | Signs and symptoms of dry eye disease |
| 14 | Enflonsia | clesrovimab-cfor | 9 Jun 2025 | Merck | Infectious disease | Biologic (BLA)Anti-RSV F protein monoclonal antibody | Fast Track | Prevention of RSV lower respiratory tract disease in neonates and infants in their first RSV season |
| 15 | Ibtrozi | taletrectinib | 11 Jun 2025 | Nuvation Bio | Oncology | Small moleculeROS1 tyrosine kinase inhibitor | OrphanBreakthroughPriority Review | Locally advanced or metastatic ROS1-positive NSCLC |
| 16 | Andembry | garadacimab-gxii | 16 Jun 2025 | CSL Behring | Hereditary angioedema | Biologic (BLA)Anti-factor XIIa monoclonal antibody | First-in-classOrphanFast Track | Prophylaxis to prevent attacks of hereditary angioedema |
| 17 | Zegfrovy | sunvozertinib | 2 Jul 2025 | Dizal Pharmaceutical | Oncology | Small moleculeEGFR tyrosine kinase inhibitor | BreakthroughPriority ReviewAccelerated Approval | NSCLC with EGFR exon 20 insertion mutations progressing on or after platinum chemotherapy |
| 18 | Lynozyfic | linvoseltamab-gcpt | 2 Jul 2025 | Regeneron | Oncology | Biologic (BLA)BCMA x CD3 bispecific antibody | OrphanFast TrackPriority ReviewAccelerated Approval | Relapsed or refractory multiple myeloma after at least four prior lines of therapy |
| 19 | Ekterly | sebetralstat | 3 Jul 2025 | KalVista Pharmaceuticals | Hereditary angioedema | Small moleculeOral plasma kallikrein inhibitor | OrphanFast Track | On-demand treatment of acute attacks of hereditary angioedema |
| 20 | Anzupgo | delgocitinib | 23 Jul 2025 | LEO Pharma | Dermatology / immunology | Small moleculeTopical pan-JAK inhibitor | Fast Track | Moderate-to-severe chronic hand eczema when topical corticosteroids are inadvisable or inadequate |
| 21 | Sephience | sepiapterin | 28 Jul 2025 | PTC Therapeutics | Rare metabolic / genetic | Small moleculePhenylalanine hydroxylase activator | Orphan | Hyperphenylalaninaemia in sepiapterin-responsive phenylketonuria, with a Phe-restricted diet |
| 22 | Vizz | aceclidine | 31 Jul 2025 | LENZ Therapeutics | Ophthalmology | Small moleculeCholinergic (muscarinic) agonist eye drop | None | Presbyopia |
| 23 | Modeyso | dordaviprone | 6 Aug 2025 | Jazz Pharmaceuticals | Oncology | Small moleculeClpP agonist / DRD2 antagonist | First-in-classOrphanPriority ReviewAccelerated Approval | Diffuse midline glioma with an H3 K27M mutation progressing after prior therapy |
| 24 | Hernexeos | zongertinib | 8 Aug 2025 | Boehringer Ingelheim | Oncology | Small moleculeHER2 tyrosine kinase inhibitor | Fast TrackBreakthroughPriority ReviewAccelerated Approval | Unresectable or metastatic NSCLC with HER2 tyrosine kinase domain activating mutations, after prior systemic therapy |
| 25 | Brinsupri | brensocatib | 12 Aug 2025 | Insmed | Respiratory | Small moleculeDPP1 inhibitor | First-in-classPriority Review | Non-cystic fibrosis bronchiectasis |
| 26 | Dawnzera | donidalorsen | 21 Aug 2025 | Ionis Pharmaceuticals | Hereditary angioedema | OligonucleotidePrekallikrein antisense oligonucleotide | First-in-classOrphan | Prophylaxis to prevent attacks of hereditary angioedema |
| 27 | Wayrilz | rilzabrutinib | 29 Aug 2025 | Sanofi | Hematology | Small moleculeBTK inhibitor | First-in-classOrphanFast Track | Persistent or chronic immune thrombocytopenia after insufficient response to prior treatment |
| 28 | Forzinity | elamipretide | 19 Sep 2025 | Stealth BioTherapeutics | Rare metabolic / genetic | PeptideCardiolipin-binding peptide | First-in-classOrphanFast TrackPriority ReviewAccelerated Approval | Improving muscle strength in Barth syndrome (patients at least 30 kg) |
| 29 | Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 19 Sep 2025 | Merck | Oncology | Biologic (BLA)Anti-PD-1 antibody, subcutaneous co-formulation | Accelerated Approval | Solid-tumour indications approved for IV pembrolizumab, in adults and patients 12 years and older |
| 30 | Palsonify | paltusotine | 25 Sep 2025 | Crinetics Pharmaceuticals | Endocrinology | Small moleculeOral nonpeptide SST2 agonist | Orphan | Acromegaly with inadequate response to, or no option for, surgery |
| 31 | Inluriyo | imlunestrant | 25 Sep 2025 | Eli Lilly | Oncology | Small moleculeOral selective oestrogen receptor degrader (SERD) | Fast Track | ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy |
| 32 | Rhapsido | remibrutinib | 30 Sep 2025 | Novartis | Dermatology / immunology | Small moleculeBTK inhibitor | First-in-class | Chronic spontaneous urticaria in adults still symptomatic despite H1 antihistamines |
| 33 | Jascayd | nerandomilast | 7 Oct 2025 | Boehringer Ingelheim | Respiratory | Small moleculePreferential PDE4B inhibitor | First-in-classOrphanBreakthroughPriority Review | Idiopathic pulmonary fibrosis |
| 34 | Lynkuet | elinzanetant | 24 Oct 2025 | Bayer | Women's health | Small moleculeNK1/NK3 receptor antagonist | First-in-class | Moderate-to-severe vasomotor symptoms due to menopause |
| 35 | Kygevvi | doxecitine and doxribtimine | 3 Nov 2025 | UCB | Rare metabolic / genetic | Small moleculePyrimidine nucleosides | First-in-classOrphanBreakthroughPriority Review | Thymidine kinase 2 deficiency with symptom onset at or before 12 years of age |
| 36 | Komzifti | ziftomenib | 13 Nov 2025 | Kura Oncology | Oncology | Small moleculeMenin inhibitor | OrphanFast TrackBreakthroughPriority Review | Relapsed or refractory acute myeloid leukaemia with a susceptible NPM1 mutation |
| 37 | Redemplo | plozasiran | 18 Nov 2025 | Arrowhead Pharmaceuticals | Cardiometabolic | OligonucleotideAPOC3-targeting siRNA | First-in-classOrphanFast TrackBreakthrough | Reducing triglycerides in adults with familial chylomicronaemia syndrome, with diet |
| 38 | Hyrnuo | sevabertinib | 19 Nov 2025 | Bayer | Oncology | Small moleculeHER2 tyrosine kinase inhibitor | OrphanBreakthroughPriority ReviewAccelerated Approval | Advanced non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations, after prior systemic therapy |
| 39 | Voyxact | sibeprenlimab-szsi | 25 Nov 2025 | Otsuka | Nephrology | Biologic (BLA)Anti-APRIL monoclonal antibody | First-in-classBreakthroughPriority ReviewAccelerated Approval | Reducing proteinuria in adults with primary IgA nephropathy at risk of progression |
| 40 | Cardamyst | etripamil | 12 Dec 2025 | Milestone Pharmaceuticals | Cardiometabolic | Small moleculeIntranasal L-type calcium channel blocker | None | Episodes of paroxysmal supraventricular tachycardia |
| 41 | Nuzolvence | zoliflodacin | 12 Dec 2025 | Innoviva Specialty Therapeutics | Infectious disease | Small moleculeBacterial type II topoisomerase inhibitor | First-in-classFast TrackPriority Review | Uncomplicated urogenital gonorrhoea due to Neisseria gonorrhoeae |
| 42 | Lerochol | lerodalcibep-liga | 12 Dec 2025 | LIB Therapeutics | Cardiometabolic | Biologic (BLA)PCSK9 inhibitor (fusion protein) | None | Lowering LDL cholesterol in adults with hypercholesterolaemia, with diet and exercise |
| 43 | Exdensur | depemokimab-ulaa | 16 Dec 2025 | GSK | Respiratory | Biologic (BLA)Long-acting anti-IL-5 monoclonal antibody | None | Add-on maintenance treatment of severe asthma with an eosinophilic phenotype |
| 44 | Myqorzo | aficamten | 19 Dec 2025 | Cytokinetics | Cardiometabolic | Small moleculeCardiac myosin inhibitor | OrphanBreakthrough | Symptomatic obstructive hypertrophic cardiomyopathy |
| 45 | Yartemlea | narsoplimab-wuug | 23 Dec 2025 | Omeros | Hematology | Biologic (BLA)Anti-MASP-2 monoclonal antibody | First-in-classOrphanBreakthroughPriority Review | Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) |
| 46 | Nereus | tradipitant | 30 Dec 2025 | Vanda Pharmaceuticals | Gastro / antiemetic | Small moleculeNK1 receptor antagonist | None | Prevention of vomiting induced by motion |
No approvals match these filters.
Name, ingredient, date and use: FDA.[1] Designations: CDER’s 2025 report.[2] Mechanism class: Kayki-Mutlu et al.[3] Sponsor names are the marketing companies at approval; check Drugs@FDA for the applicant of record. Underlined drug names open Laafon’s full analysis.
Full Laafon analyses of individual 2025 approvals
33 of the 46 approvals have a detailed review on Laafon covering mechanism, pivotal trial data, dosing and safety. Listed by approval date.
The pathway labels in this table, and what each one commits FDA to
Accelerated Approval
Approval on a surrogate endpoint reasonably likely to predict clinical benefit. The sponsor must run confirmatory trials, and FDA can withdraw the approval if they fail.[5]
Vanrafia, Avmapki Fakzynja Co-Pack, Emrelis, Zegfrovy, Lynozyfic, Modeyso, Hernexeos, Forzinity, Keytruda Qlex, Hyrnuo, Voyxact
Priority Review
FDA aims to act on the application within 6 months instead of the standard 10. It shortens the review clock; it does not lower the evidence standard.[5]
Journavx, Gomekli, Romvimza, Blujepa, Imaavy, Avmapki Fakzynja Co-Pack, Emrelis, Ibtrozi, Zegfrovy, Lynozyfic, Modeyso, Hernexeos, Brinsupri, Forzinity, Jascayd, Kygevvi, Komzifti, Hyrnuo, Voyxact, Nuzolvence, Yartemlea
Breakthrough Therapy
Early clinical evidence of substantial improvement over available therapy on a clinically significant endpoint. It buys intensive FDA guidance during development.[5]
Journavx, penpulimab-kcqx, Avmapki Fakzynja Co-Pack, Emrelis, Ibtrozi, Zegfrovy, Hernexeos, Jascayd, Kygevvi, Komzifti, Redemplo, Hyrnuo, Voyxact, Myqorzo, Yartemlea
Fast Track
For a serious condition with an unmet medical need. It allows more frequent FDA meetings and rolling submission of the application.[5]
Journavx, Gomekli, Romvimza, Qfitlia, penpulimab-kcqx, Imaavy, Enflonsia, Andembry, Lynozyfic, Ekterly, Anzupgo, Hernexeos, Wayrilz, Forzinity, Inluriyo, Komzifti, Redemplo, Nuzolvence
Orphan designation
For a disease affecting fewer than 200,000 people in the US. It is an incentive (including seven years of marketing exclusivity on approval), not a review pathway.[6]
Grafapex, Gomekli, Qfitlia, penpulimab-kcqx, Imaavy, Avmapki Fakzynja Co-Pack, Ibtrozi, Andembry, Lynozyfic, Ekterly, Sephience, Modeyso, Dawnzera, Wayrilz, Forzinity, Palsonify, Jascayd, Kygevvi, Komzifti, Redemplo, Hyrnuo, Myqorzo, Yartemlea
First-in-class
CDER’s own label for a mechanism of action not previously approved. It is an analytical tag, not a regulatory designation.[2]
Journavx, Blujepa, Qfitlia, Avmapki Fakzynja Co-Pack, Emrelis, Tryptyr, Andembry, Modeyso, Brinsupri, Dawnzera, Wayrilz, Forzinity, Rhapsido, Jascayd, Lynkuet, Kygevvi, Redemplo, Voyxact, Nuzolvence, Yartemlea
What a US novel approval means for India
A US approval does not make a drug approved in India. Each of these needs CDSCO permission under the New Drugs and Clinical Trials Rules, 2019 before import or manufacture. Since 7 August 2024, CDSCO has allowed the local clinical trial to be waived under Rule 101 for certain categories — orphan drugs, cell and gene therapies, pandemic or special-defence drugs, and drugs with a significant therapeutic advance — when the drug is already approved in the US, UK, EU, Japan, Australia or Canada.[7]
For Indian formulators, these 46 molecules are mostly patent-protected in the US for years; their practical value today is as a pipeline signal for API process development and future regulated-market filings. If you are planning a US filing, the USFDA approval roadmap for Indian formulation plants sets out the facility side.
FDA novel drug approvals 2025: questions we get asked
FDA’s Center for Drug Evaluation and Research approved 46 novel drugs in 2025, from Datroway on 17 January to Nereus on 30 December. That compares with 50 in 2024 and 55 in 2023. The count excludes cell and gene therapies, vaccines and biosimilars.
A novel drug is a new molecular entity or new therapeutic biologic whose active ingredient has never before been approved or marketed in the US. It does not need a new mechanism of action; first-in-class status is tracked separately, and 20 of the 46 2025 approvals had it.
No. Biosimilars rely on an already-licensed reference product, so they are not novel. Cell and gene therapies, vaccines and blood products are licensed by FDA’s Center for Biologics Evaluation and Research and are reported separately from CDER’s novel drug list.
Oncology, with 16 of the 46 approvals by Laafon’s grouping, including four kinase inhibitors for non-small cell lung cancer (Ibtrozi, Zegfrovy, Hernexeos, Hyrnuo) and two antibody-drug conjugates (Datroway, Emrelis). Rare disease is spread across areas: 23 approvals carried orphan designation, half of the year’s total.
33 of 46 (72%) used at least one of Fast Track, Breakthrough Therapy, Priority Review or Accelerated Approval. Priority Review was the most common (21), followed by Fast Track (18), Breakthrough Therapy (15) and Accelerated Approval (11).
Not automatically. Each needs CDSCO permission under the New Drugs and Clinical Trials Rules, 2019. Since August 2024, the local clinical trial can be waived for some categories, such as orphan drugs, when the drug is already approved in the US or another notified country, but a CDSCO application is still required.
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- FDA novel drug approvals 2026 trackerThe live list for the current year, updated as FDA adds approvals.
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- USFDA pre-approval inspection checklistWhat FDA investigators check at a PAI and how to prepare.
Sources
- U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Novel Drug Approvals for 2025. Silver Spring (MD): FDA; content current as of 8 Jul 2026. Available from: fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed Oct 2026.
- U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Advancing Health Through Innovation: New Drug Therapy Approvals 2025. Silver Spring (MD): FDA; Jan 2026. Available from: fda.gov/media/190705/download. Accessed Oct 2026.
- Kayki-Mutlu G, Aksoyalp ZS, Wojnowski L, Michel MC. A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2025. Naunyn Schmiedebergs Arch Pharmacol. 2026;399(8):11157-79. Available from: doi.org/10.1007/s00210-026-05193-0. Accessed Oct 2026.
- Society of Chemical Industry. The FDA approved these 46 new drugs in 2025. SCI News; Jan 2026 (prior-year CDER totals). Available from: soci.org/news/2026/1/the-fda-approved-these-46-new-drugs-in-2025. Accessed Oct 2026.
- U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. Silver Spring (MD): FDA. Available from: fda.gov/patients/learn-about-drug-and-device-approvals. Accessed Oct 2026.
- U.S. Food and Drug Administration, Office of Orphan Products Development. Frequently Asked Questions (FAQ) about Designating an Orphan Product. Silver Spring (MD): FDA. Available from: fda.gov/industry/designating-orphan-product-drugs-and-biological-products. Accessed Oct 2026.
- Regulatory Affairs Professionals Society. Asia-Pacific Roundup: India waives local trial requirement for drugs approved in select countries (CDSCO notice under Rule 101, 7 Aug 2024). Regulatory Focus; Aug 2024. Secondary source; the CDSCO notice itself should be read before relying on it. Available from: raps.org. Accessed Oct 2026.
This page is a technical and educational summary for pharmaceutical professionals. It is not medical, legal or investment advice. Approved uses are summaries; the current US prescribing information on Drugs@FDA governs, and Indian regulatory positions (CDSCO notices, NDCT Rules) change frequently. Last verified against FDA sources on 29 Oct 2026.
