-
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
18 Sep 2024 16:26 GMT
Drug Sponsor
Sponsor
Medical Review
Clinical Pharmacology Review
Statistical … )
None
BPCA
Deferasirox - Exjade
Novartis Pharmaceuticals Corporation
Medical (PDF - 9 MB …
Golimumab - Simponi
Janssen Biotech, Inc.
Medical (PDF - 3.1 MB …
-
Promoting Adherence to Iron Chelation Treatment in Beta-Thalassemia Patients
07 Jun 2022 08:23 GMT
… adhere well to prescribed drug treatment.47 Patients who … sessions with his doctor and specialist nurse … Therapeutics plc, and Agios Pharmaceuticals Ltd, outside the submitted … and accounting for medication adherence in clinical trials. Clin Pharmacol …
-
Novartis delivers solid Q3 results, with strong growth in Innovative Medicines. Announces strategic review of Sandoz
26 Oct 2021 06:57 GMT
… global leader in generic pharmaceuticals and biosimilars. Its global … knee NIS793 Granted FDA orphan drug designation in combination … cancer Results from ongoing trials and other highlights … create transformative treatments in areas of great medical need. In …
-
Novartis Pharmaceuticals Agrees to Pay $678M to Settle Doctor-Bribe Claims
02 Jul 2020 15:30 GMT
… sales of its Exjade and Myfortic drugs. Exjade reduces iron levels … doctors to choose the best treatment for their patients and increases drug … charitable foundations to pay Medicare patients’ co-pays in … is US v. Novartis Pharmaceutical Corp., 11-cv-0071, …
-
Glenmark Pharmaceuticals receives ANDA approval for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg
07 Jan 2020 11:12 GMT
… States Food & Drug Administration (U.S. FDA) for Deferasirox Tablets … the generic version of Exjade®1 Tablets for Oral … 500 mg, of Novartis Pharmaceuticals Corporation.
According to IQVIA™ … ending November 2019, the Exjade® Tablets for Oral Suspension, …
-
Glenmark Pharmaceuticals gets USFDA approval for Deferasirox tablets
07 Jan 2020 17:48 GMT
Glenmark Pharmaceuticals on Tuesday said … United States Food & Drug Administration (USFDA) for Deferasirox … generic version of exjade tablets of Novartis Pharmaceuticals Corporation, the company … period ending November 2019, exjade tablets had annual sales …
-
Novartis takes on Sanofi, Amgen with $9.7 bln takeover of heart drug maker
25 Nov 2019 08:37 GMT
… medicines from Amgen Inc (AMGN.O), Sanofi (SASY.PA) and Regeneron Pharmaceuticals … the U.S. biotechnology company’s lone drug, the cholesterol- … not just rare disease treatments, as it did in … overload medicine Exjade and $3.3 billion-per-year MS drug Gilenya …
-
Alembic Pharma gets USFDA nod for generic chronic iron overload treatment tablets
22 Nov 2019 10:06 GMT
… the United States Food and Drug Administration (USFDA) for its … versions of Novartis Pharmaceuticals Corporation’s Jadenu tablets and Exjade tablets for … , Alembic Pharmaceuticals said.
Deferasirox tablets are indicated for the treatment of chronic …
-
Oncology/Cancer Blockbuster Drugs Market: Global Industry Analysis and Opportunity Assessment, 2019 – 2025
31 May 2019 07:03 GMT
… the global cancer blockbuster drugs market dynamics, opportunities, … for global cancer blockbuster drugs market. The report … Votubia
24. Neulasta
25. Exjade Jadenu
26. Sandostatin
27. … Top 27 Cancer Blockbuster Drugs Market Assessment & Opportunity …