USFDA gives nod to Cipla for Lanreotide injection

The company said it has received final approval for Lanreotide Injection from the USFDA

283
USFDA Approval
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market.

The company said it has received final approval for Lanreotide Injection from the US Food and Drug Administration (USFDA).

The USFDA approval is based on new drug application (NDA), it added.

The Lanreotide injection is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Cipla MD and Global CEO Umang Vohra said, “This approval is a significant step for our US business and is in line with our aspiration to continue growth in our complex product pipeline and address unmet patient needs.”

The company’s product is generic equivalent of Ipsen Biopharmaceuticals Inc’s Somatuline Depot.

According to IQVIA, Somatuline Depot had US sales of around USD 867 million for the 12-month period ended October 2021.

USFDA gives Orphan Drug Designation to Zydus for malaria treatment

USFDA relaxes restriction on Abortion Pill

USFDA approved Finasteride, Tadalafil for new treatment for Benign Prostatic Hyperplasia

USFDA issues Form 483 to Alembic Pharma Gujarat plant

USFDA approves generic drug for Blood Pressure

CDSCO panel’s nod to Sun Pharma for Rosuvastatin Sprinkle Capsules

USFDA gives Orphan Drug Designation to Zydus for malaria treatment

Parliament passes Surrogacy (Regulation) Bill

USFDA relaxes restriction on Abortion Pill

Medical Devices: Current scenario and need of the hour

Govt introduces amendment Bill, decriminalising use of biological resources by ‘Vaids’,…

Govt notifies NIB, Noida as CDL to test Covid-19 vaccines

FDA Haryana and police unearthed a unit manufacturing spurious cosmetics

Recruitment of 87 Drug Inspectors put on hold in Maharashtra

Latest Notifications regarding Pharmaceuticals

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