January 2

Glycopyrrolate Oral Solution – Aurobindo Pharma
www.aurobindousa.com/news/product-news/aurobindo-receives-fda-approval-for-glycopyrrolate-oral-solution-1-mg-5-ml/

January 13

Tretinoin Gel – Aurobindo Pharma
www.aurobindousa.com/news/product-news/aurobindo-receives-fda-approval-for-tretinoin-gel-usp-0-01/

January 20

Acetaminophen/Ibuprofen Tablets (OTC) – Strides Pharma
www.strides.com/pdf/pressrelease/2025/SEIntimationJan20.pdf

January 21

Phytonadione Injectable Emulsion Single Dose Ampules Launch – Glenmark Pharmaceuticals
https://glenmark.b-cdn.net/gpl_pdfs/media/Press%20Release_Glenmark%20launches%20Phytonadione%20Injectable%20Emulsion%20USP%2010%20mg.pdf

January 23

Memantine/Donepezil Extended-Release Capsules – Amneal Pharmaceuticals
https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U.S.-FDA-Approval-for-MemantineDonepezil-Extended-Release-Capsules-and-Everolimus-Tablets-for-Oral-Suspension-and-Tentative-U.S.-FDA-Approval-for-Rifaximin/default.aspx

January 24

Sacubitril/Valsartan Tablets – Lupin Pharmaceuticals
www.lupin.com/lupin-receives-u-s-fda-approval-for-sacubitril-and-valsartan-tablets/

January 29

Sirolimus Oral Solution Launch – Camber Pharmaceuticals
www.camberpharma.com/camber-launches-sirolimus-oral-solution/

January 31

Avtozma® Injection – Biosimilar To Actemra®
www.celltrionusa.com/board/newslist/30

January 17

Datroway® For Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
www.daiichisankyo.com/files/news/pressrelease/pdf/202501/20250117_E.pdf
www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-us-for-1l-mcl.html

January 22

Grafapex™ Injection For Allogeneic Hematopoietic Stem Cell Transplantation Patients With Acute Myeloid Leukemia Or Myelodysplastic Syndrome
www.medexus.com/en_US/news-media/press-releases/detail/176/medexus-announces-fda-approval-of-grafapex-treosulfan-for

January 30

Journavx™ Tablets For Moderate-To-Severe Acute Pain
https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

January 15

Niktimvo™ Injection 9 mg and 22 mg – New Vial Sizes
https://ir.syndax.com/news-releases/news-release-details/incyte-and-syndax-announce-us-food-and-drug-administration-fda

Omvoh® Injection For Crohn’s Disease – New Indication
https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease

January 17

Calquence® Tablets + Chemoimmunotherapy For Previously Untreated Mantle Cell Lymphoma – New Indication
www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-us-for-1l-mcl.html

Lumakras® Tablets + Vectibix® For Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer – New Indication
https://investors.amgen.com/news-releases/news-release-details/fda-approves-lumakrasr-sotorasib-combination-vectibixr

January 21

Spravato® Nasal Spray (C-III)-The First & Only Monotherapy For Treatment-Resistant Depression – New Indication
www.investor.jnj.com/news/news-details/2025/Spravato-esketamine-approved-in-the-U.S.-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression/default.aspx

January 26

Leqembi® For Early Alzheimer’s Disease – New Dosing Regimen
https://media-us.eisai.com/2025-01-26-FDA-Approves-Leqembi-R-lecanemab-irmb-IV-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease
https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-lecanemab-irmb-iv-maintenance-dosing

January 27

Enertu® Injection – First HER2-Directed Therapy For HER2-Low Or HER2-Ultralow Metastatic Breast Cancer Following Disease Progression After One Or More Endocrine Therapies – New Indication
www.daiichisankyo.com/files/news/pressrelease/pdf/202501/20250127_E.pdf
www.astrazeneca-us.com/media/press-releases/2025/Enertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-her2-directed-therapy-for-patients-with-her2-low-or-her2-ultralow-metastatic-breast-cancer-following-disease-progression-after-one-or-more-endocrine-therapies.html

January 28

Ozempic® Injection – 3 New Indications
www.novonordisk-us.com/media/news-archive/news-details.html?id=915253

January 6

Cisatracurium Besylate Injection By Teva
https://dps.fda.gov/drugshortages/discontinuations/cisatracurium-besylate-injection

January 14

Ambrisentan Tablets By Apotex Corp.
https://dps.fda.gov/drugshortages/discontinuations/ambrisentan-tablet 

January 27

Bendamustine HCl Injection By Aptoex Corp.
https://dps.fda.gov/drugshortages/discontinuations/bendamustine-hydrochloride-injection

January 30

Altace® Capsules
https://dps.fda.gov/drugshortages/discontinuations/ramipril-capsule

March 25
Cisatracurium Besylate Injection Launch – Hikma Pharmaceuticals
www.hikma.com/news/hikma-launches-cisatracurium-besylate-injection-usp-in-the-us/

March 3
Otulfi® Injection – Biosimilar To Stelara®
SOURCE 1: Fresenius Kabi USA, LLC of Lake Zurich, Illinois, March 3
www.fresenius-kabi.com/us/news-and-events/fresenius-continues-growth-of-biosimilars-portfolio-with-the-us-availability-of-otulfi-ustekinumab-aauz
SOURCE 2: Formycon AG of Munich, Germany, March 3
www.formycon.com/en/blog/press-release/fyb202-otulfi-ustekinumab-aauz-a-biosimilar-to-stelara-launched-in-the-united-states-and-the-european-union/

Stoboclo® & Osenvelt® Injections – Biosimilars Referencing Prolia® & Xgeva®
www.celltrionusa.com/board/newslist/31

March 10
Omlyclo® Injection – Biosimilar To Xolair®
www.celltrionusa.com/board/newslist/33

March 12
Steqeyma® Injection (Biosimilar To Stelara®) – Now Available
www.celltrionusa.com/board/newslist/34