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Results For "FDA"

2080 News Found

UFDA approves first generic of Symbicort to treat asthma and COPD
Drug Approval | March 16, 2022

UFDA approves first generic of Symbicort to treat asthma and COPD

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)


Granules Pharmaceuticals clears USFDA audit
News | March 15, 2022

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility


USFDA grants Orphan Drug Designation for Akantior
Biotech | March 15, 2022

USFDA grants Orphan Drug Designation for Akantior

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets


USFDA approves Zydus’ Colestipol Hydrochloride tablets
Drug Approval | March 14, 2022

USFDA approves Zydus’ Colestipol Hydrochloride tablets

It is only the second generic application approved by the USFDA


Alembic receives USFDA tentative approval for hypertension drug
Drug Approval | March 14, 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region


Adlarity receives USFDA approval for treatment of Alzheimer
Drug Approval | March 14, 2022

Adlarity receives USFDA approval for treatment of Alzheimer

First and only once-weekly patch for convenient, well-tolerated delivery of most used drug for the treatment of Alzheimer's-related dementia


Strides receives USFDA approval for Colchicine tablets
Drug Approval | March 11, 2022

Strides receives USFDA approval for Colchicine tablets

Colchicine tablets are used for the treatment and prevention of gout. It reduces inflammation which causes pain, swelling and other symptoms of gout


USFDA approves Lupin’s Vigabatrin oral solution
Drug Approval | March 11, 2022

USFDA approves Lupin’s Vigabatrin oral solution

The product will be manufactured at Lupin’s facility in Goa, India


USFDA approves Evoke Spinal Cord Stimulation System
Drug Approval | March 09, 2022

USFDA approves Evoke Spinal Cord Stimulation System

Transformative closed-loop technology senses the spinal cord's response to stimulation and instantaneously adjusts therapy to sustain durable, optimized treatment