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Us Food And Drug Administration

Glenmark Pharma Inks Settlement Pact With Pfizer For Cancer Drug

Glenmark Pharma Inks Settlement Pact With Pfizer For Cancer Drug

Pfizer Inc and Glenmark Pharmaceuticals announced on Tuesday that they have reached a settlement over a cancer treatment drug.

22 November 2022

Lupin Gets USFDA Nod For Generic Blood Pressure Lowering Drug

The Mumbai-based company said it has received the nod from the US Food and Drug Administration (FDA) to market Azilsartan Medoxomil tablets


Zydus Gets USFDA Nod To Market Generic Blood Pressure Lowering Drug

The company has received final approval from the US Food and Drug Administration (USFDA) to sell Norepinephrine Bitartrate Injection


Zydus Lifesciences Gets USFDA Nod For Generic Drug

The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing

03 October 2022

Sun Pharma, Glenmark Recall Products In US Due To Manufacturing Issues

A US-based unit of Sun Pharma is recalling 50,680 vials of Testosterone Cypionate Injection, used to treat low testosterone in adult males, in the American market


Lupin Gets USFDA Nod For Generic Drug

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ivacaftor tablets, 150 mg strength.

08 June 2022

Indoco Remedies' CRO Clears USFDA Inspection With No Observation

As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related...

19 September 2022

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Zydus Gets USFDA Nod For Generic Antacid

The company has received approval from the US Food and Drug Administration to market the drug in the strengths of 20mg and 40mg, the company said in a statement.

06 June 2022

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10 May 2022
Sun Pharma Gets Form 483 From USFDA For Regulatory Violations At Halol Plant

Sun Pharma Gets Form 483 From USFDA For Regulatory Violations At Halol Plant

The US Food and Drug Administration conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022, the...


21 March 2022
Alembic Pharma Gets USFDA Nod For Lacosamide Tablet

Alembic Pharma Gets USFDA Nod For Lacosamide Tablet

The approval by the USFDA is for the abbreviated new drug application (ANDA) for Lacosamide Tablets of strengths 50 mg, 100 mg, 150mg, and 200 mg.


08 February 2022
Lupin Gets USFDA Nod For Generic Version Of Arformoterol Tartrate Inhalation Solution

Lupin Gets USFDA Nod For Generic Version Of Arformoterol Tartrate Inhalation Solution

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of arformoterol tartrate inhalation solution 15...


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