LEO Pharma Taclonex (calcipotriene and betamethasone dipropionate) topical suspension, 0.005%/0.064% has won FDA approval for body plaque psoriasis. With the approval, the only once-daily, steroid-containing topical treatment is now ...
Tags: body plaque psoriasis, Medicine
The US Food and Drug Administration (FDA) has approved Eisai's non-competitive AMPA glutamate receptor antagonist for patients who continue to have seizures despite being on other prescription medications for epilepsy. The drug, ...
US Food and Drug Administration (FDA) has approved an update to the labeling for Bristol-Myers Squibb's Baraclude to include data on African Americans and liver transplant recipients with chronic hepatitis B infection. The present ...
The US Food and Drug Administration (FDA) has granted clearance to Fenwal for two new indications for collection of plasma products on its cell separation devices, thus providing blood centers more flexibility to collect plasma on mobile ...
Tags: cell separation devices, collection of plasma products, plasma products
Mylan Pharmaceuticals has won FDA approval for its abbreviated new drug application (ANDA) for Irbesartan Tablets USP, 75mg, 150mg and 300mg, the generic version of Sanofi's Avapro. The FDA has also approved the company's ANDA for ...
Tags: FDA approval, ANDA, Irbesartan Tablets
The USFDA has approved Abbott's Humira (adalimumab) for the treatment of adult patients with moderate to severe Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Humira, which works by inhibiting tumour ...
Tags: FDA, Abbott Humira, Ulcerative Colitis
LensAR cataract procedures carried out in US 26 Sep 2012 The country's first commercial procedures using the LensAR femtosecond platform have taken place in two locations. The LensAR Laser System LensAR,the Florida-based vendor of ...
Tags: LensAR, LenSx, OptiMedica, Technolas PV, Laser System, Cataract
Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult patients with depressive episodes ...
Tags: FDA, sNDA, atypical class of drugs, bipolar depression
The USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm. Lidocaine is an amide-type local anesthetic agent and is suggested to ...
Toumaz has completed the acquisition of Frontier Silicon. Toumaz,a developer of specialist medical sensors and low power wireless chips,announced in July it had agreed to acquire Frontier Silicon,the digital radio chipset developer for ...
Tags: Toumaz, completed the acquisition of Frontier Silicon, 32.3m pounds
AbGenomics International, a biopharmaceutical company, has obtained FDA agreement on Its Phase 2 clinical trial plans of the novel autoimmune therapeutic candidate, AbGn-168H. The current Phase 2 AbGn-168H trial will be a multicenter, ...
Tags: FDA approval, psoriatic, clinical trial, pharmaceutical product
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. ...
Tags: FDA, sNDA, pharmaceutical product, clinical development
Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. The approved ...
Tags: Medicine, Etomidate Injection, Hospira's Amidate injection
The US Food and Drug Administration (FDA) has approved ZALTRAP (ziv-aflibercept) injection to be used in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) that is ...
Tags: Zaltrap Injection, Medicine
Qualitest Pharmaceuticals, a generic pharmaceutical company, has won the US Food and Drug Administration (FDA) approval for abbreviated new drug application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg. The ...