Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 24

Results For "tentative-approval"

251 News Found

Alembic JV receives final approval for Mupirocin cream
Drug Approval | November 17, 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Gland Pharma receives tentative nod for Sugammadex injection
Drug Approval | October 09, 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery


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