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Results For "United-States"

1202 News Found

Zydus receives final approval from USFDA for Triazolam Tablets
Drug Approval | December 31, 2022

Zydus receives final approval from USFDA for Triazolam Tablets

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)


Claim against Dr. Reddy’s Laboratories dismissed over Revlimid in US
News | December 30, 2022

Claim against Dr. Reddy’s Laboratories dismissed over Revlimid in US

All claims against the company in the litigation have now been dismissed.


Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
Drug Approval | December 29, 2022

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore


Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya
Policy | December 26, 2022

Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya

Centre and states need to work in tandem and in a collaborative spirit as was done during the previous surges for COVID-19 prevention and management


Lupin receives USFDA approval for Brivaracetam Tablets
Drug Approval | December 23, 2022

Lupin receives USFDA approval for Brivaracetam Tablets


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

None of the observations are related to data integrity and management believes that they are addressable


Aurigene reports results of AUR101 in phase II study in US patients
News | December 19, 2022

Aurigene reports results of AUR101 in phase II study in US patients

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients


Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise
News | December 15, 2022

Briefs: Jubilant Pharmova and Apollo Hospitals Enterprise

The company will submit an action plan on the observations and will engage with US FDA for next steps.