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

395 News Found

Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Aurobindo Pharma receives 10 observations for Unit IX
Drug Approval | November 21, 2022

Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US


Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Drug Approval | November 09, 2022

Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India


Zydus receives EIR with VAI from USFDA for Moraiya facility
Drug Approval | November 08, 2022

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)


Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


Zydus receives final approval from USFDA for Acetaminophen injection
Drug Approval | October 30, 2022

Zydus receives final approval from USFDA for Acetaminophen injection

Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.