Alembic gets USFDA final nod for Erlotinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva Tablets, 25 mg, 100 mg, and 150 mg, of OSI Pharmaceuticals.

84
USFDA
Picture: Pixabay

Last Updated on July 11, 2021 by The Health Master

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Erlotinib Tablets, 25 mg, 100 mg, and 150 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva Tablets, 25 mg, 100 mg, and 150 mg, of OSI Pharmaceuticals.

Medicine Tablets
Picture: Pixabay

Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Erlotinib Tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Erlotinib Tablets, 25 mg, 100 mg, and 150 mg, have an estimated market size of $37 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from USFDA.

Alembic gets USFDA nod for drug for the treatment of Depression

USFDA approves Abbott’s Stent to treat high bleeding risk patients

Zydus Cadila gets USFDA nod for drug to treat HIV infection

Alembic gets USFDA nod for Nitrofurantoin Capsules USP

Axio Biosolution gets USFDA nod for Patch for bleeding control

Glenmark gets USFDA nod for generic Lung cancer drug

All Legislation of India (for Pharma and Health professionals)

Latest Notifications: General (Pharmaceuticals)

Starch powder sold as Black Fungus medicine: Scam busted

Fake Favipiravir racket busted: FIR lodged

Delhi High Court set up IPD for Pharma Industry

ER for D Pharmacy is a step in right direction: Pharmacy…

Telegram
WhatsApp
Facebook
LinkedIn
Google-news

Enter your email address:

Delivered by FeedBurner