Last Updated on October 17, 2024 by The Health Master
Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie.
Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired). Aleor had previously received tentative approval for this ANDA.
Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of US$ 86 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 138 ANDA approvals (122 final approvals and 16 tentative approvals) from USFDA.
Also read:
Cipla gets US FDA approval for generic drug for Migraine
Lupin launches generic Penicillamine tablets
NATCO launches Epilepsy Tablets in India
ICPA launches antibiotic for Dental treatment
Zydus Cadila gets USFDA nod for Anti Depressant drug
Granules gets USFDA nod for Acetaminophen, Aspirin and Caffeine tablets
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
