Merck receives EC approval for Winrevair for treatment of PAH

Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)

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

Lupin receives Health Canada approval for biosimilar Pegfilgrastim

Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim

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

Sequent Scientific receives WHO prequalification approval for Albendazole API

This is in partnership with Mepro Pharmaceuticals which have successfully developed and commercialised the Albendazole Chewable formulation

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients

Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.

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)