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Results For "New-Drug-Application"

339 News Found

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


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


Poxel and Sumitomo Dainippon gets TWYMEEG approval
News | June 25, 2021

Poxel and Sumitomo Dainippon gets TWYMEEG approval

The TWYMEEG approval is supported by numerous preclinical and clinical studies, including the Phase 3 TIMES (Trials of IMeglimin for Efficacy and Safety) program managed jointly by both the companies


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


Sun Pharma’s US Specialty business to grow at 21% CAGR in 2 years
News | June 14, 2021

Sun Pharma’s US Specialty business to grow at 21% CAGR in 2 years

The company expects to see steady performance led by new launches and gradual normalization post the scale-up in vaccination


TLC partners Strides to launch Mucormycosis drug in India
News | May 28, 2021

TLC partners Strides to launch Mucormycosis drug in India

Mucormycosis drug AmphoTLC will be imported from Taiwan by Stelis Biopharma Private Limited (Stelis), the biotech arm of Strides group, and will be launched and distributed in India immediately by Strides


Zydus and TLC sign agreement to market Liposomal Amphotericin B in India
News | May 26, 2021

Zydus and TLC sign agreement to market Liposomal Amphotericin B in India

With the surge of infections in India in the recent days AmphoTLC will address the country's acute liposomal amphotericin B shortage