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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.
“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. For more information, please contact Ryan Collins, CEO, at 1-201-292-1289.


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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