The FDA approved over 100 drugs in 2013, ranging from oncology medications to weight loss drugs. LGM Pharma carries newly approved API's and can provide these to clients, along with support throughout the research and development process. The FDA also regularly adds new indications to already approved drugs, and LGM Pharma can provide these API's, as well as consistent guidance and support during the entire R&D cycle.
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.
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.
Approved as a medication to treat major depressive disorder in adults, Levomilnacipran is designed as a once daily dose.
LGM Pharma's insight:
The FDA approved Fetzima (Levomilnacipran) July 2013. Approved as a medication to treat major depressive disorder in adults, Levomilnacipran is designed as a once daily dose. As a serotonin and norepinephrine reuptake inhibitor (SNRI), results from several Phase lll studies of Levomilnacipran revealed marked success in treating patients. The FDA approval will be helpful to future patients worldwide, and crucial for the 15 million Americans who are suffering from depression currently.
TopoTarget: FDA Accepts Filing Of Beleodaq Investing.com TopoTarget's, (TOPO) belinostat, now with the brand name Beleodaq, could be approved on 9 August 2014 (PDUFA date). The FDA has accepted the product filing and granted priority review.
FDA declared a Breakthrough Therapy designation for Dabrafenib to treat metastatic BRAF V600E mutation-positive non-small cell lung cancer.
LGM Pharma's insight:
On January 14, 2014 the FDA declared a Breakthrough Therapy designation for Dabrafenib, also known as the brand name Tafinlar as a single agent to treat certain types of lung cancer, specifically for the treatment of metastatic BRAF V600E mutation-positive non-small cell lung cancer. The target patient population should have already previously received one line of platinum-containing chemotherapy.
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