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Results For "USFDA"

1210 News Found

Lupin receives approval from USFDA for Arformoterol Tartrate inhalation
Drug Approval | February 08, 2022

Lupin receives approval from USFDA for Arformoterol Tartrate inhalation

Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)


USFDA approves first generic of Restasis
Drug Approval | February 03, 2022

USFDA approves first generic of Restasis

Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug


Alembic receives USFDA tentative approval for fesoterodine fumarate
Drug Approval | February 02, 2022

Alembic receives USFDA tentative approval for fesoterodine fumarate

The tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


Alembic receives USFDA approval for clarithromycin tablets
Drug Approval | February 01, 2022

Alembic receives USFDA approval for clarithromycin tablets

Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA


USFDA approves Genentech’s Vabysmo to treat causes of vision loss
Drug Approval | January 31, 2022

USFDA approves Genentech’s Vabysmo to treat causes of vision loss

Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need


Granules Pharmaceuticals concludes USFDA audit with three minor observations
News | January 31, 2022

Granules Pharmaceuticals concludes USFDA audit with three minor observations

The audit is a PAI for two of its product applications filed from this facility


Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy
Drug Approval | January 26, 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Medtronic gets USFDA approval of spinal cord stimulation therapy
Medical Device | January 25, 2022

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone