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FDA Approved 2014


The recent approval of two low dosage strengths of Indomethacin have been a boon for Iroko Pharmaceuticals. The FDA approved their twenty and forty milligram doses of the popular nonsteroidal anti-inflammatory drug under the brand name Tivorbex. As easy to swallow capsules, the approval of the lower dose Indomethacin will likely lead to fewer adverse[…]

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On March 11, 2014 the FDA approved Topiramate, marketed as Qudexy™ XR by Upsher-Smith Laboratories, for the treatment of partial-onset seizures (POS) or primary generalized tonic-clonic seizures in patients 10+ years of age. It is also approved as adjunctive therapy in patients 2+ years of age for the aforementioned seizures, and seizures associated with Lennox-Gastaut[…]

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The FDA recently approved Droxidopa, known as the brand name Northera, to treat neurogenic orthostatic hypotension, which is a common complication of Parkinson’s disease. Neurogenic orthostatic hypotension or NOH is an uncommon but dangerous drop in blood pressure that presents upon standing. Patients with NOH exhibit symptoms like severe dizziness, a faint feeling, weakness, fatigue[…]

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On January 10, 2014 the FDA announced the accelerated approval for a drug combination consisting of Trametinib (Mekinist) and Dabrafenib (Tafinlar) to treat patients with unresectable melanoma. Patients approved to receive this treatment must have the BRAF V600E mutations or BRAF V600K mutations of metastatic melanoma. Additionally, patients must have the BRAF V600E or V600K[…]

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As an anti-diabetic medication and selective inhibitor of the sodium glucose co-transporter type 2 (SGLT2), Dapagliflozin is now approved by the FDA for the treatment of type 2 diabetes mellitus. The Dapagliflozin FDA approval was announced January 13, 2014, as the brand name Farxiga, which is marketed by Bristol-Myers Squibb. The unique ability of Dapagliflozin[…]

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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