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Results For "Abbreviated-New-Drug-Application"

249 News Found

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


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


Caplin gets USFDA approval for Sumatriptan
News | July 15, 2021

Caplin gets USFDA approval for Sumatriptan

Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache


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


Cipla receives final approval for generic version of Brovana
News | June 24, 2021

Cipla receives final approval for generic version of Brovana

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.’s Brovana


Sun Pharma settles patent litigation for Revlimid
News | June 23, 2021

Sun Pharma settles patent litigation for Revlimid

Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules