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Results For "United-States-Food-and-Drug-Administration"

395 News Found

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Zydus granted Orphan Drug Designation by USFDA for ZYIL1
Drug Approval | March 22, 2023

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit
Drug Approval | March 19, 2023

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature


Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Drug Approval | March 18, 2023

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.


Zydus receives final approval from the USFDA for Olanzapine
News | March 13, 2023

Zydus receives final approval from the USFDA for Olanzapine

Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions


USFDA completes inspection of Lupin’s Vizag facility
Drug Approval | March 11, 2023

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations


Zydus receives final approval from the USFDA for Erythromycin Tablets
Drug Approval | March 10, 2023

Zydus receives final approval from the USFDA for Erythromycin Tablets

Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body