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[…]
Unique Formulation of Indomethacin Gains FDA Approval
Analgesic, Anti-Inflammatory, FDA Approved 2014, OTC and Compounding Product Tags: NSAID Mar 18, 2014
Topiramate Approved as Antiepileptic Drug
Anti-Migraine, Anti-Obesity Product, FDA Approved 2014 Tags: Annual MeetingepilepsyTopiramate Mar 14, 2014
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[…]
Droxidopa Approved for Parkinson’s-Related Hypotension
Anti-Parkinsons, Drug Research & Development API, FDA Approved 2014 Tags: hypertension Feb 28, 2014
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[…]
Accelerated Approval for Trametinib and Dabrafenib Combination
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Approved 2014 Tags: 1195765-45-7Dabrafenib and TrametinibMekinistmetastatic melanomaTafinlarTrametinibunresectable melanoma Jan 29, 2014
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[…]
Dapagliflozin FDA Approval for Type 2 Diabetes
Anti-Diabetic, Drug Research & Development API, FDA Approved 2014 Tags: anti-diabeticDapagliflozinHbA1ctype 2 Diabetes Jan 17, 2014
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[…]
