As per the USFDA, it may designate a drug as a CGT after determining that there is inadequate generic competition for that drug
Alembic has a cumulative total of 183 ANDA (abbreviated new drug application) approvals from the US Food & Drug Administration
Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market
The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg, Zydus said in a regulatory filing.
The company has received approval from the US Food and Drug Administration (USFDA) to market Gabapentin tablets which are indicated for the management of postherpetic neuralgia (PHN)
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults, Zydus Lifesciences said
The company has also received final approval from the US Food and Drug Administration (USFDA) to market Pregabalin capsules in multiple strengths, the...
As per IQVIA MAT August 2022 data, Valbenazine capsules had annual sales of USD 781 million in the US
The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity
FDA had earlier implemented a temporary pause on Covaxin trials, following the WHO's observations on Covaxin manufacturing plants in India.
The company has received tentative approval from the United States Food and Drug Administration for its abbreviated new drug application for Tenofovir...
The approval granted by the US Food and Drug Administration is for the abbreviated new drug application Desvenlafaxine extended-release tablets of strength 25...