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Results For "approval"

2608 News Found

Biocon Pharma receives USFDA approval for daptomycin
Drug Approval | September 01, 2024

Biocon Pharma receives USFDA approval for daptomycin

The approval further adds to Biocon’s portfolio of complex drug products


Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Drug Approval | August 28, 2024

Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg

Also received tentative approval for 137 mg


Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%
Drug Approval | August 28, 2024

Lupin receives USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.1%

Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Merck receives EC approval for Winrevair for treatment of PAH
Drug Approval | August 27, 2024

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
Drug Approval | August 27, 2024

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)


Lupin receives Health Canada approval for biosimilar Pegfilgrastim
News | August 23, 2024

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
Drug Approval | August 21, 2024

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
News | August 20, 2024

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