USFDA approval granted for the generic Lanreotide injection

This USFDA approval is a major win for Cipla, solidifying their presence in the high-value U.S. market.

124
USFDA Drug product Approval
USFDA Approval

Last Updated on June 10, 2024 by The Health Master

USFDA approval

Indian pharmaceutical giant Cipla has achieved a significant milestone, receiving final U.S. Food and Drug Administration (USFDA approval) for its generic Lanreotide Injection.

This injectable medication represents a cost-effective alternative for treating patients with acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Highly Affordable Treatment Option for Acromegaly and GEP-NETs

Cipla’s Lanreotide Injection is a biosimilar, or therapeutic equivalent, to the brand-name drug Somatuline Depot (lanreotide) Injection.

This means it offers the same efficacy and safety profile as the brand-name medication, but at a potentially significantly lower price.

Acromegaly and GEP-NETs are rare diseases, and having an accessible treatment option can significantly improve patient outcomes.

Pre-Filled Syringes for Ease of Use

Cipla’s Lanreotide Injection comes in convenient, single-dose pre-filled syringes.

This eliminates the need for complex medication preparation and ensures accurate dosing.

The pre-filled syringes are available in three strengths:

  • 120 mg/0.5 mL
  • 90 mg/0.3 mL
  • 60 mg/0.2 mL

Large Market Potential for Cipla

According to IQVIA (IMS Health), Somatuline Depot generated approximately $898 million in sales within the U.S. for the year ending March 2024.

Cipla’s generic Lanreotide Injection has the potential to capture a significant share of this market, offering substantial cost savings for patients and healthcare providers alike.

Cipla’s Entry Strengthens US Market Position

This USFDA approval is a major win for Cipla, solidifying their presence in the high-value U.S. market.

The generic Lanreotide Injection aligns with Cipla’s strategy of expanding its portfolio of complex generic drugs and reflects their commitment to providing affordable treatment options for patients worldwide.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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