FDA Approves Glycopyrrolate Orally Disintegrating Tablets for peptic ulcer
PARSIPPANY, N.J. - The Food and Drug Administration has granted approval for Dartisla ODT (glycopyrrolate) in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
DARTISLA ODT (glycopyrrolate) orally disintegrating 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. 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., zEdenbridge'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."
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