Aleor Dermaceuticals gets USFDA nod for Testosterone Gel

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie.

85
USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 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:

USFDA United State Food and Drugs Administration
USFDA

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:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news