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Results For "tentative-approval"

257 News Found

Zydus Cadila gets US FDA approval for antidepressant tablets
Drug Approval | September 09, 2021

Zydus Cadila gets US FDA approval for antidepressant tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.


Alembic JV Aleor receives US FDA final approval for skin disorder gel
Drug Approval | September 06, 2021

Alembic JV Aleor receives US FDA final approval for skin disorder gel

Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea


Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
Drug Approval | August 27, 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials


Lupin receives tentative U.S. FDA approval for Brivaracetam tablets
Drug Approval | August 17, 2021

Lupin receives tentative U.S. FDA approval for Brivaracetam tablets

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older


Alembic gets USFDA nod for Clomipramine Hydrochloride
News | August 05, 2021

Alembic gets USFDA nod for Clomipramine Hydrochloride

It had an estimated market size of US $ 32 million as of June 2021


NATCO Pharma transfers Lenalidomide ANDA to Arrow
News | August 04, 2021

NATCO Pharma transfers Lenalidomide ANDA to Arrow

Arrow is the marketing partner in US


Alembic announces USFDA approval for Desipramine Hydrochloride Tablets
News | July 09, 2021

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets

The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA


Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets
News | July 01, 2021

Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets

TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis


Sun Pharma Q4 FY21 net profit up 124%
News | May 27, 2021

Sun Pharma Q4 FY21 net profit up 124%

The company reported net profit for FY21 at Rs. 2,903.8 crore, lower by 23% over last year