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Results For "New-Drug-Application"

456 News Found

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children
Drug Approval | March 12, 2024

USFDA grants orphan drug and pediatric exclusivities for Cresemba for aspergillosis and mucormycosis in children

CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


Lupin receives approval from USFDA for Minzoya
Drug Approval | February 17, 2024

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)


Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets
Drug Approval | January 04, 2024

Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets

Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis