Global Reach Health

October 14, 2020

Wakix Receives Expanded Indication

October 14, 2020 – The U.S. FDA has approved an expanded indication for Wakix® (pitolisant), manufactured by Harmony Biosciences. The drug is now indicated to treat
October 13, 2020

FDA Emphasizes Proper Insulin Pen Dispensing

October 13, 2020 – The U.S. FDA has issued a safety communication in regard to proper dispensing of insulin pens. These products should typically be dispensed in their original
October 5, 2020

Makena Market Withdrawal Proposed

October 5, 2020 – The U.S. FDA’s Center for Drug Evaluation and Research (CDER) has proposed that Makena® (hydroxyprogesterone caproate injection – AMAG Pharmaceuticals)
October 2, 2020

Marksans Expands Metformin ER Recall

October 2, 2020 – Marksans Pharmaceuticals has voluntarily expanded its June 5, 2020, recall of Metformin Hydrochloride Extended-Release (ER) Tablets, USP 500mg and 750mg
October 2, 2020

Opdivo and Yervoy Approved for Mesothelioma

October 2, 2020 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab) used in combination with Yervoy® (ipilimumab) to provide first-line treatment of adults
October 2, 2020

Teva Launches Truvada and Atripla Generics

October 2, 2020 – Teva Pharmaceuticals has announced the launch of generics for Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and Atripla (efavirenz/
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