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Results For "U.S.-FDA"

291 News Found

Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).


Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
Drug Approval | November 08, 2023

Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets

This product will be manufactured at Lupin’s Pithampur facility in India


Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023


USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis
Drug Approval | October 20, 2023

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials


Glenmark receives ANDA approval for Apremilast Tablets
Drug Approval | October 18, 2023

Glenmark receives ANDA approval for Apremilast Tablets

Glenmark's current portfolio consists of 188 products authorized for distribution in the US


Lupin enters into BTA with Lupin Manufacturing Solutions
News | October 17, 2023

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions


Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution
Drug Approval | October 13, 2023

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)


Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa
Supply Chain | September 28, 2023

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries