Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg). The Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg) ...
Tags: ONE DOSE, levonorgestrel tablet, Watson Pharmaceuticals
The US Food and Drug Administration (FDA) has approved the use of Associates of Cape Cod's rapid diagnostic test in detecting invasive fungal infections (IFI). Using patient's blood serum, the Fungitell assay detects (1,3)-b-D-glucan ...
Tags: detecting invasive fungal infections, fungal pathogens, IFI
Soligenix has received FDA clearance for SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) investigational new drug (IND) application for the induction treatment of pediatric Crohn's disease. With the IND clearance, ...
Pluristem Therapeutics, a developer of placenta-based cell therapies, is seeking FDA orphan drug status for its PLacental eXpanded (PLX) cells for the treatment of aplastic anemia. Pluristem earlier received an orphan drug status from the ...
Auxilium Pharmaceuticals and Actelion Pharmaceuticals Canada have announced Health Canada notice of compliance (approval) for Xiaflex (collagenase clostridium histolyticum or CCH) to treat Dupuytren's contracture in adults with a palpable ...
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
US-based ingredient firm Z Trim has announced that the FDA has approved the labeling of Z Trim products in meat applications.With this decision,the FDA has cleared the use of Z Trim ingredients in ground,emulsified,and processed meats and ...
Tags: label, processed meats, poultry, food processors, costs
Global pharmaceutical company Sucampo has received a supplement approval from the US Food and Drug Administration (FDA) for updates to AMITIZA (lubiprostone) pregnancy labeling. The approval removes pregnancy 'warnings and precautions' ...
Tags: pharmaceutical, supplement, labeling, lubiprostone, FDA, labeling changes
Quidel has received FDA 510(k) clearance for its Quidel Molecular Influenza A+B assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. Quidel received FDA clearance in December 2011 to run its Quidel ...
Tags: Quidel, FDA 510(k)clearance, Quidel Molecular Influenza A+B assay
US-based consumer healthcare company Ganeden Biotech has received US Food and Drug Administration (FDA) Generally Recognized As Safe (GRAS) status for GanedenBC30 (Bacillus coagulans GBI-30, 6086), a spore-forming probiotic ingredient. ...
Tags: healthcare company, spore-forming probiotic ingredient
Absorption Systems has launched new assay for the human breast cancer resistance protein (BCRP) transporter. The new assay will enable drug developers to test new drug candidates for interactions with BCRP, which is involved in drug ...
Tags: Absorption Systems, breast cancer resistance protein transporter
Supernus Pharmaceuticals has received approval from the FDA for its Oxtellar XR, a new once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug used as an adjunct therapy to treat partial seizures in ...
Tags: oxcarbazepine, FDA approval, partial seizure, pharmaceutical product
Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone. ...
Tags: FDA, alogliptin, clinical trial program
Amcom Software, a subsidiary of USA Mobility, has launched version 5.0 of the Amcom Critical Test Results Management solution. The enhanced version features notable enhancements, particularly integration with the Amcom Mobile Connect ...
The US Food and Drug Administration (FDA) is warning consumers not to eat cantaloupes from Burch Equipment, a firm based in North Carolina, as they may be contaminated with Listeria monocytogenes (L. mono). This warning comes after Burch ...
Tags: cantaloupes, listeria monocytogenes, gastrointestinal problems