India-based Dr. Reddy's Laboratories has announced the launch of Zenatane (Isotretinoin Capsules USP) in 20mg and 40mg strengths in the US. The launch follows the FDA approval of the company's ANDA for Zenatane 10mg, 20mg and 40mg. ...
Tags: Zenatane, FDA, Isotretinoin Capsules
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
The US Food and Drug Administration (FDA) has approved Biogen Idec's Tecfidera (dimethyl fumarate), a new first-line oral capsule for people suffering from relapsing forms of multiple sclerosis (MS). Tecfidera reduces relapses and ...
Tags: FDA, Biogen capsule, multiple sclerosis
Becton, Dickinson and Company (BD) has announced the FDA approval of first drug, diphenhydramine hydrochloride injection, USP, to be offered in BD Simplist line of prefilled generic injectables. Diphenhydramine Hydrochloride Injection, ...
Tags: FDA, drug, prefilled generic injectables
BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical ...
Tags: BioControl Medical, FDA, Medical
Posted by Jack Mans -- Packaging Digest, 3/25/2013 12:22:33 PM The U.S. Department of Energy has approved of the first bionic eye for use in the U.S. The creation of this retinal prosthesis stems, in part, from DOE support for a decade of ...
Tags: FDA, Packaging, Packaging Digest
c (tobramycin inhalation powder) 28mg per capsule has obtained FDA approval for the treatment of bacterial lung infection in certain cystic fibrosis (CF) patients. TOBI Podhaler is new non-nebulized formulation and delivery system of ...
Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The ...
Tags: Quidel, Life Technologies, FDA Approval
The US Food and Drug Administration (FDA) has granted six months pediatric exclusivity for Hospira's Precedex (dexmedetomidine HCl) injection in the US. Precedex, an alpha-2 agonist, is approved for use only in adults and the US regulator ...
Tags: Hospira Precedex injection, Drug, FDA
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%), ...
The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel product indicated for use in lymphatic mapping procedure. The lymphatic mapping procedure ...
Tags: FDA, Biopharmaceuticals, Navidea Biopharma
Biogen Idec is seeking marketing approval from the US Food and Drug Administration (FDA) for recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy to treat hemophilia A. The company has submitted a biologics license application ...
Tags: Biogen Idec, FDA, hemophilia A
Baxter has submitted a biologics license application (BLA) supplement to the US Food and Drug Administration (FDA) for the approval of its prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, ...
Tags: Baxter, Feiba NF Drug, Medicine
Biopharmaceutical company Amarin has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for the marketing and sale of its Vascepa(R) (icosapent ethyl) capsules. Vascepa is ...
Tags: Amarin, Vascepa Capsule, FDA
Food and Drug Administration (FDA) has approved US-based pharmaceutical company Shionogi's Osphena (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginal atrophy ...
Tags: FDA, Dyspareunia, Medicine