Shilpa Medicare gets USFDA tentative nod for drug for Arthritis

Shilpa Medicare gets USFDA tentative nod for drug for Arthritis

99
USFDA Approval
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Shilpa Medicare has received US Food and Drug Administration (USFDA) tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021.

The ANDA was filed as ‘First to File’ submission on NCE -1 date to seek eligibility for 180 days exclusivity.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene used in the treatment of ‘psoriatic arthritis’ as recommended in the label approved by FDA.

According to IQVIA MAT Q2 2020 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $2.4 billion.


Also read:

Aleor Dermaceuticals gets USFDA nod for Testosterone Gel

Unichem gets USFDA nod for Guanfacine Tablets

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

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