Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg

Also received tentative approval for 137 mg

Alembic receives FDA final approval for Betamethasone Valerate Foam, 0.12%

Indoco Remedies receives final ANDA approval from the USFDA for Lofexidine Tablets 0.18 mg

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals

Zydus receives final approval from USFDA for Valbenazine Capsules

Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)

Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical

CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India