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Results For "New-Drug-Application"

340 News Found

Granules receives ANDA approval for anti-depressant medication
Drug Approval | February 03, 2022

Granules receives ANDA approval for anti-depressant medication

It has a total of 50 ANDA approvals from USFDA


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


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


Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq
Drug Approval | January 28, 2022

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq

Potassium chloride is used to prevent or to treat low blood levels of potassium


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


Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


Glenmark receives U.S. FDA approval for Ryaltris
Drug Approval | January 14, 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


Marksons Pharma receive final US. FDA approval for Cetirizine Hydrochloride tablets
Drug Approval | January 12, 2022

Marksons Pharma receive final US. FDA approval for Cetirizine Hydrochloride tablets

The product will be marketed under store brand labels and is comparable to the brand Zyrtec