Edenbridge Pharmaceuticals Announces U.S. FDA Approval of DARTISLA ODT (Glycopyrrolate) Orally Disintegrating Tablets

Rhea-AI Summary

Edenbridge Pharmaceuticals has received FDA approval for DARTISLA ODT, its first 505(b)(2) branded drug. This orally disintegrating tablet, containing 1.7 mg of glycopyrrolate, is indicated for adults to alleviate peptic ulcer symptoms. DARTISLA ODT is notable as the first and only orally disintegrating tablet formulation of glycopyrrolate. The product is set to launch in early 2022, marking a significant milestone for Edenbridge as it expands into the branded specialty prescription market.

Positive

• Approval of DARTISLA ODT signifies a successful FDA 505(b)(2) NDA process.
• DARTISLA ODT is the first and only orally disintegrating tablet of glycopyrrolate, providing a competitive market advantage.
• Pending launch in early 2022 could drive revenue growth as part of Edenbridge's specialty drug portfolio.

Negative

• Patients at risk for anticholinergic toxicity or who are hypersensitive to glycopyrrolate cannot use DARTISLA ODT.

- Edenbridge’s first 505(b)(2) branded drug to be granted FDA approval

- DARTISLA ODT is available as a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer

- First and only orally disintegrating tablet (ODT) of glycopyrrolate

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Edenbridge Pharmaceuticals, LLC (“Edenbridge”) today announced that it has received approval from the U.S. Food and Drug Administration on its 505(b)(2) New Drug Application (NDA) for DARTISLA ODT (glycopyrrolate) orally disintegrating tablets. DARTISLA ODT is available in a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Edenbridge will launch this product to the market in early 2022 as its first branded specialty prescription product.

“We are thrilled to receive approval for DARTISLA ODT, which will provide physicians and patients with a novel treatment option,” remarked Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and Associate General Counsel. “This marks a major milestone for Edenbridge as our first 505(b)(2) NDA to receive approval from the FDA. We look forward to this new chapter for our company as we continue our strategic expansion into branded specialty prescription products.”

DARTISLA ODT is manufactured by Catalent (NYSE: CTLT) using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.

Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. Please visit www.Dartisla.com and consult the full prescribing information for additional important information.

About Edenbridge

Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. For more information, visit www.edenbridgepharma.com or contact the Company directly at info@edenbridgepharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211217005400/en/

Daniel G. Worley Jr., PharmD, RPh, Esq.

Vice President, Business Development & Associate General Counsel

201-479-1336

dworley@edenbridgepharma.com

Source: Edenbridge Pharmaceuticals, LLC

FAQ

What is DARTISLA ODT approved for?

DARTISLA ODT is approved for adults to reduce symptoms of a peptic ulcer as an adjunct treatment.

When will DARTISLA ODT be available?

DARTISLA ODT is set to launch in early 2022.

What makes DARTISLA ODT unique?

It is the first and only orally disintegrating tablet formulation of glycopyrrolate.

What company manufactures DARTISLA ODT?

DARTISLA ODT is manufactured by Catalent.

What are the adverse reactions associated with DARTISLA ODT?

Adverse reactions include blurred vision, drowsiness, and dry mouth, among others.