Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/23/2013 5:04:22 PM The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride ...
Genalice, a US-based software solutions developer for DNA analysis, will soon release the beta version of Genalice Map. The solution Genalice Map can process raw DNA data, which is produced by the sequencers, and stores the data in a ...
Tags: Genalice, Raw DNA Sequence Data
The USFDA has approved Amarin supplemental new drug application for Chemport as additional Vascepa active pharmaceutical ingredient supplier. The approval adds to the company's planned expansion of the Vascepa manufacturing supply chain ...
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Allergan's New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. In addition ...
Tags: Migraine Therapy, Medicine
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg. The company has begun the shipment of the product ...
Interdisciplinary Centre for Mathematical and Computational Modeling (ICM) at University of Warsaw in Poland, has selected IBM Blue Gene/Q, a single architecture supercomputer, to support the country's biomedical and biotechnological ...
Tags: ICM, IBM Supercomputer, Biomedical Research Initiative
KannaLife Sciences has partnered with Advanced Neural Dynamics and IteraMed for the discovery of new neuroprotectants. As part of the agreement, KannaLife will fund a new drug discovery project related to a laboratory validated ...
Tags: KannaLife Sciences, Neuroprotectants Discovery, Medicine
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%. Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International. Mylan ...
Tags: FDA, Acyclovir Ointment, Medicine
The US FDA has approved Teva Pharmaceutical Industries' new drug application (NDA) for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets as oral contraceptives. Quartette, designed as next generation of extended ...
Tags: Health, Medicine, oral contraceptives
Janssen Research & Development is seeking US FDA approval for the use of Simeprevir (TMC435) in combination with pegylated interferon and ribavirin to treat genotype 1 chronic hepatitis C in adults. The company submitted a new drug ...
Tags: Health, Medicine, pegylated interferon
BioDelivery Sciences International and Arcion Therapeutics have signed a worldwide licensing deal for the development and commercialization of topical clonidine gel (previously ARC4558) to treat painful diabetic neuropathy (PDN) and other ...
Tags: BioDelivery, Arcion Therapeutics, topical clonidine gel development
Boehringer Ingelheim and Eli Lilly and Company have announced the submission of new drug application (NDA) to FDA for an investigational type 2 diabetes mellitus (T2D) treatment, empagliflozin. Empagliflozin belongs to sodium glucose ...
Tags: diabetes therapy, drug application, drug
The US Food and Drug Administration (FDA) has approved Mylan Specialty's abbreviated new drug application for the generic equivalent to Sunovion's Xopenex inhalation solution, Levalbuterol inhalation solution USP, 0.31mg/3mL (0.0103%), ...