Granules India gains ANDA approval for Trazodone tablets
The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health
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Browsing Tag
US FDA
Novartis’ kidney disease drug Fabhalta receives US FDA approval
Fabhalta specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the…
FDA approves first Nalmefene Hydrochloride auto-injector to reverse opioid overdose
The newly approved product delivers 1.5 milligrams (mg) of nalmefene under the skin (subcutaneous) or into muscle (intramuscular)…
Lupin gets USFDA nod for Prednisolone Acetate Ophthalmic Suspension USP
Lupin was granted a Competitive Generic Therapy designation (CGT) for this product, and being the first approved applicant, Lupin…
Axxelent receives its first US FDA Establishment Inspection Report (EIR)
The US FDA inspected the facility from June 17 to 21, 2024
US FDA flags dosing risks from compounded versions of Novo’s weight-loss drug
Regulator highlights risks of dosing errors and adverse events, urges healthcare providers to ensure correct syringe use and…
Oral JAK inhibitor LEQSELVI (deuruxolitinib) approved by US FDA for severe alopecia areata treatment
LEQSELVI delivered statistically significant efficacy across two Phase 3 clinical trials
Pfizer’s gene therapy for Haemophilia A receives positive topline results from Phase 3 Study
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
Zydus receives final US FDA nod for Valsartan Tablets
Valsartan tablets had annual sales of $149.5 mn in the United States (IQVIA MAT May 2024)
Zydus gains final FDA nod for Sacubitril and Valsartan Tablets
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and…