Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B. ...
Tags: FDA, IB1001, intravenous recombinant factor IX protein
Medtronic has obtained regulatory clearance from the US Food and Drug Administration (FDA) for the expanded indication of use of its tubular stent graft for the endovascular repair of isolated lesions (excluding dissections) of the ...
Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product. The product, a generic version of Novartis' Lescol ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) has received approval from the US Food and Drug Administration (FDA). Truvada is the first agent to get approval for HIV prevention in uninfected adults, a strategy ...
Tags: HIV testing, Truvada, PrEP, pre-exposure prophylaxis
The US Food and Drug Administration (FDA) has cleared Sigma-Tau Pharmaceuticals' topical ophthalmic therapeutic to treat corneal cystine crystals in cystinosis patients. The CYSTARAN 0.44% solution, which is developed in collaboration ...
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia
GlaxoSmithKline (GSK) has received FDA approval for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The approval is based on the results of the randomized, ...
Tags: advanced soft tissue sarcoma, STS, soft tissue sarcomas, GlaxoSmithKline
Arena Pharmaceuticals and Eisai have announced FDA approval of Belviq (lorcaserin HCl) for chronic weight management in adults who are overweight with comorbidity or obese. The FDA approved Belviq as an adjunct to a reduced-calorie diet ...
Tags: Belviq, lorcaserin HCl, chronic weight management, Arena Pharmaceuticals
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has won FDA abbreviated new drug application approval for Diclofenac Sodium and Misoprostol Delayed-Release Tablets. The company plans to launch Diclofenac Sodium and ...
Tags: Watson Laboratories
Perrigo Company, a healthcare company, has won final FDA approval for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will immediately begin the shipment of Morphine sulfate oral solution, a ...
Tags: Perrigo Company, morphine sulfate, morphine sulfate oral solution
Gilead Sciences has received US Food and Drug Administration (FDA) approval for Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild is a complete once-daily single tablet ...
Wockhardt, a high-technology intensive pharmaceutical and biotechnology company, has gained tentative FDA approval for marketing Ziprasidone, a generic anti-psychotic drug Geodon. The FDA approved generic version of 20mg, 40mg, 60mg and ...
Novartis has obtained the US Food and Drug Administration (FDA) approval for a new 13.3 mg/24 h dosage strength of its Exelon Patch (rivastigmine transdermal system), designed to treat patients with mild to moderate Alzheimer's disease. ...
Tags: Alzheimer's disease, Novartis Pharmaceuticals, Exelon Patch