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May 27, 2022
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Amantadine Hydrochloride Tablets, 100mg, a generic version of Symmetrel®* Tablets, 100mg. Amantadine Hydrochloride Tablets, 100mg, are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Tablets, 100mg, are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. For more information please contact the Company directly at info@edenbridgepharma.com.


April 19, 2022
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Doxepin Hydrochloride Capsules USP, 150mg, a generic version of Sinequan Capsules, 150mg. Edenbridge will begin shipping this newly approved product shortly. For more information please contact the Company directly at info@edenbridgepharma.com.


February 28, 2022
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that DARTISLA ODT (glycopyrrolate) is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies.
"DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers" noted Daniel G. Worley Jr., Edenbridge's Vice President of Business Development and General Counsel. "Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most."
"Phil is proud to support Edenbridge's commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT." said Deepak Thomas, Founder and CEO of Phil.
The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. 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.
For more information on the DARTISLA ODT Copay Program and available savings offers, visit www.dartisla.com/copay-card.
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.


December 17, 2021
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC 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.


October 6, 2021
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Loperamide Hydrochloride Capsules USP, 2 mg, a generic version of Imodium®* Capsules, 2mg. Loperamide Hydrochloride Capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. For more information please contact the Company directly at info@edenbridgepharma.com.


August 12, 2021
Parsippany, New Jersey. Edenbridge Pharmaceuticals is aware of interest in and media reports related to the potential use of Ivermectin for the prevention and/or treatment of COVID-19. Edenbridge's Ivermectin tablets, USP (3mg) are not approved by the U.S. Food and Drug Administration (FDA) for use in the prevention or treatment of COVID-19. However, in light of the ongoing global pandemic and reports throughout the scientific and medical communities related to Ivermectin, Edenbridge is supporting certain clinical trials to study the safety and effectiveness of Ivermectin for the treatment of COVID-19. As these studies are ongoing, no further comment or information is available at this time.
Edenbridge Pharmaceuticals is also aware of unsubstantiated reports of fake or recalled lots of its Ivermectin tablets, USP (3mg). Edenbridge Pharmaceuticals' Ivermectin tablets, USP (3mg) were approved for human use by the FDA in 2014 for the treatment of strongyloidiasis of the intestinal tract and onchocerciasis. Since that time and to date, no lot of this product has been recalled or is currently being recalled.
Edenbridge Pharmaceuticals utilizes a contract manufacturer and two contract packagers for its Ivermectin tablets, USP (3mg). The manufacturer and both packagers are located in the United States and are all in good standing with the FDA and routinely audited. Due to differences in packaging equipment, there are some slight differences in the packaging. The printing on the blisters may be different in one lot versus another, including differences in font and character formation (e.g., a slash through the zeros). In addition, the blister card and carton may vary slightly in width and the blister or bubble may vary slightly in size. While these differences may have raised some concerns, they are all necessary to properly package the product with relevant quality controls in place to ensure a complete seal of the blister and accurate printing on the blisters.
More information on Edenbridge Pharmaceuticals' Ivermectin tablets, USP (3mg) can be found in the package insert for the product available here.


August 9, 2021
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has successfully filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for methenamine mandelate tablets USP, 500mg and 1,000mg. This filing joins another Edenbridge 505(b)(2) NDA already pending approval before the FDA for an orally disintegrating tablet (ODT) of glycopyrrolate filed in February 2021. "These two 505(b)(2) NDAs represent a significant achievement for Edenbridge, and we look forward to working with existing partners and identifying new ones to commercialize these products in the near future as our Company expands its footprint into branded prescription products" remarked Edenbridge's CEO Ryan Collins. For more information, please contact the Company directly at info@edenbridgepharma.com.


June 14, 2021
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Aminocaproic Acid Tablets USP, 500 mg, a generic version of Amicar®* tablets, 500mg. Aminocaproic Acid Tablets USP, 500 mg, are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. For more information please contact the Company directly at info@edenbridgepharma.com.


September 21, 2020
Parsippany, New Jersey. Edenbridge Pharmaceuticals announces the launch of its miglustat capsules 100mg.
Generic version of Zavesca®* capsules being distributed by Orsini Specialty Pharmacy and offered with a co-pay program for eligible patients.
Edenbridge Pharmaceuticals, LLC announces the launch of miglustat capsules 100mg. Edenbridge's miglustat capsules 100mg are a generic version of Zavesca®* (miglustat capsules 100mg) and are being distributed through Orsini Specialty Pharmacy, a nationwide, independent specialty pharmacy focused on rare diseases and gene therapies. As part of its launch, Edenbridge is offering a co-pay program for eligible patients. "Our launch of miglustat in the U.S. is a significant step for Edenbridge in improving the lives of patients and families with rare diseases" notes Edenbridge’s CEO Ryan Collins.
This product launch and U.S. FDA approval follows Edenbridge's 2017 approval by the European Medicines Agency (EMA) of the first generic version of Zavesca®* to receive approval through the centralized procedure for sale in all EMA member states.


September 17, 2020
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that the World Health Organization (WHO) has added Edenbridge's Ivermectin Tablets USP (3mg) to its Prequalified Medicines List. This marks the first ivermectin product in the world to be added to the Prequalified Medicines List by the WHO Prequalification Team. For more information please contact the Company directly at info@edenbridgepharma.com.


July 13, 2020
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (2.5mg/6.25mg, 5mg/6.25mg, and 10mg/6.25mg), a generic version of Ziac®* tablets (2.5mg/6.25mg, 5mg/6.25mg, and 10mg/6.25mg). Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated in the management of hypertension. Edenbridge intends to begin shipping this newly approved product shortly. For more information please contact the Company directly at info@edenbridgepharma.com.


November 19, 2019
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Diltiazem Hydrochloride Tablets, USP (30 mg, 60 mg, 90 mg, and 120 mg), a generic version of Cardizem®* tablets (30 mg, 60 mg, 90 mg, and 120 mg). Edenbridge intends to begin shipping this newly approved product shortly. For more information please contact the Company directly at info@edenbridgepharma.com.


May 14, 2019
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Albendazole Tablets USP 200mg, a generic version of Albenza®* tablets (Albendazole Tablets 200mg). Edenbridge intends to begin shipping this newly approved product shortly. For more information please contact the Company directly at info@edenbridgepharma.com.


November 30, 2018
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Etodolac Tablets, USP, a generic version of Lodine®* tablets (Etodolac Tablets). Etodolac Tablets are indicated for acute and long-term use in the management of the signs and symptoms of Osteoarthritis and Rheumatoid Arthritis. It is also indicated for the management of acute pain. Edenbridge intends to begin shipping this newly approved product shortly and it will be available in both 400mg and 500mg strengths. For more information please contact the Company directly at info@edenbridgepharma.com.


February 6, 2017
Parsippany, New Jersey. Edenbridge Pharmaceuticals announces Yargesa (100mg miglustat capsules) receives CHMP Positive Opinion. Final approval will be first European Union-wide generic of Actelion's Zavesca®* through the centralized procedure.
Edenbridge Pharmaceuticals, LLC announces that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Yargesa (100mg miglustat capsules). The total market for miglustat capsules in the EU is estimated to be €50 million and Edenbridge is exploring partnering, licensing and divestiture opportunities.
About Yargesa. Yargesa is a generic version of Actelion Registration Ltd's Zavesca®* (100mg miglustat capsules) and is intended for treatment of adult patients with mild to moderate type 1 Gaucher disease. Bioequivalence of Yargesa was demonstrated through an in-vivo bioequivalence study against the reference product Zavesca®* currently marketed in the EU. The Marketing Authorisation application was submitted to the EMA by JensonR+ Limited as applicant on behalf of Edenbridge and the final decision from the European Commission is expected within a few months. When approved, Yargesa will be the first generic version of Zavesca®* approved through the centralized procedure for sale in all EMA member states.
About the CHMP. The CHMP is the scientific committee of the European Medicines Agency (EMA) and recommends medicines for Marketing Authorization across the member states of the European Union.
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“We are proud to have developed and achieved the first generic alternative to Zavesca®* through the centralized procedure to address this growing need in all EMA member states” notes Patrick Chu, President of Edenbridge Pharmaceuticals.


December 22, 2016
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for its Prednisolone Sodium Phosphate Oral Solution (10mg Prednisolone per 5ml & 20mg Prednisolone per 5ml). Edenbridge intends to begin shipping this newly approved product shortly. For more information please contact the Company directly at info@edenbridgepharma.com.


June 30, 2016
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Valeant Pharmaceuticals' Edecrin®* tablets (Ethacrynic Acid Tablets 25mg). Prior to today, there have been no FDA approved generic versions of Edecrin®* tablets and Edenbridge intends to begin shipping its Ethacrynic Acid Tablets USP 25mg product shortly. Ethacrynic Acid is a potent diuretic indicated for the treatment of edema. For more information please contact the Company directly at info@edenbridgepharma.com.


February 17, 2016
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Lodosyn®* (Carbidopa Tablets 25mg). Edenbridge will begin shipping its Carbidopa Tablets 25mg shortly. Carbidopa tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of Parkinson's Disease. For more information please contact the Company directly at info@edenbridgepharma.com.


September 28, 2015
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has partnered with Validus Pharmaceuticals LLC to launch an exclusive authorized generic version of Bumex®* (bumetanide tablets). Edenbridge's Bumetanide Tablets in 0.5mg, 1mg and 2mg dosage strengths will begin shipping shortly. Bumetanide is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. For more information please contact the Company directly at info@edenbridgepharma.com.


August 4, 2015
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Tindamax®* (Tinidazole Tablets 250mg & 500mg). Edenbridge will begin shipping its Tinidazole Tablets 250mg & 500mg products shortly. This is Edenbridge's second FDA approval and one of several products filed by Edenbridge with the FDA. Tinidazole is a synthetic antiprotozoal and antibacterial agent for oral administration. For more information please contact the Company directly at info@edenbridgepharma.com.


October 24, 2014
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Merck & Co., Inc.'s Stromectol®* (Ivermectin Tablets 3mg). Prior to today, there have been no FDA approved generic versions of Stromectol® and Edenbridge intends to begin shipping its Ivermectin Tablets USP 3mg product shortly. This is Edenbridge's first FDA approval and one of several products filed by Edenbridge with the FDA over the last three years. Ivermectin is a semisynthetic, anthelmintic agent for oral administration. For more information please contact the Company directly at info@edenbridgepharma.com.


April 19, 2012
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC, is pleased to announce the launch of Zidovudine Capsules, USP and Zidovudine Syrup (Oral solution, USP). Edenbridge's Zidovudine products are FDA approved generic versions of Retrovir®*. For more information, please visit our updated Products page or contact us directly at info@edenbridgepharma.com.


April 6, 2012
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC, is pleased to announce the launch of Stavudine for Oral Solution, USP. Edenbridge's Stavudine is the only FDA approved generic version of Zerit®* for Oral Solution currently available on the market. For more information, please visit our updated Products page or contact us directly at info@edenbridgepharma.com.


August 16, 2010
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC, is pleased to announce the launch of its newest product Opium Tincture, USP (Deodorized). For more information, please visit our updated Products page or contact us directly at info@edenbridgepharma.com.


February 1, 2010
Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC, is pleased to announce the launch of its first product Methenamine Mandelate Tablets, USP. Methenamine Mandelate Tablets, USP, are available in two convenient dosage strengths, 500mg and 1,000mg tablets. For more information, please visit our updated Products page or contact us directly at info@edenbridgepharma.com.


 

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