Glenmark Pharmaceuticals granted Ezetimibe, Simvastatin tablets in USA

Custom Synthesis,Glenmark Pharmaceuticals granted Ezetimibe, Simvastatin tablets in USA

Indian Glenmark Pharmaceuticals has been granted final approval by the U.S. FDA for Ezetimibe and Simvastatin Tablets, for several doses.

Glenmark said that, referring to to IQVIA sales data for the 12-month period ending April 2019, the Vytorin Tablets market achieved annual sales of approximately $92.4 million.

Glenmark’s current portfolio consists of 157 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement

(1) Cannabidiol oral solution (CBD) Oral Solution, the fastest progress, is in phase 3 for infantile spasm indications.

According to clinical data from Clinical Trails, GW Phama, UK, ranked first in 84 clinical trials, Mannheim Central Institute of Mental Health, Germany, submitted 13 registered clinical trials, and Zynerba Pharmaceuticals and Insys Therapeutics Inc, USA, ranked third and fourth in 11 and 10 respectively.

(2) Application for Naloxone * Nasal Spray was submitted in the first quarter of 2019.

(3) Previously, in August 2018, Insys Therapeutics’505b2 modified new drug, Epinephrine* Nasal Spray, was approved by the FDA Fast Track Qualification for the treatment of acute, life-threatening allergic reactions.

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