Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 28

Results For "Abbreviated-New-Drug-Application"

294 News Found

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


Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


Natco announces launch of 10 mg Everolimus in the US
Drug Approval | October 01, 2021

Natco announces launch of 10 mg Everolimus in the US

According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021


Biocon settles suit with Celgene for generic Revlimid
Biotech | September 08, 2021

Biocon settles suit with Celgene for generic Revlimid

Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020


Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


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


US district court favours Pharmacyclics against Natco on Imbruvica
News | August 20, 2021

US district court favours Pharmacyclics against Natco on Imbruvica

In 2018 NATCO and Alvogen had filed an Abbreviated New Drug Application (ANDA) with PIV certification for the generic version of the product


Ind-Ra predicts growth in US sales for Indian pharma from H2FY22
News | August 18, 2021

Ind-Ra predicts growth in US sales for Indian pharma from H2FY22

Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume


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


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol