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%), ...
The US Food and Drug Administration (FDA) has approved Par Pharmaceutical Companies' abbreviated new drug application (ANDA) for fluvoxamine maleate 100mg and 150mg extended-release (ER) capsules. Fluvoxamine maleate ER capsules are ...
Tags: FDA, Drug, fluvoxamine maleate ER
The US Food and Drug Administration (FDA) has accepted Neos Therapeutics' new drug application (NDA) 505(b)(2) filing for NT0202, an extended release (XR) orally disintegrating tablet (ODT) formulation of Amphetamine Polistirex. The ...
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Nuvo Research's US licensing partner, Mallinckrodt, following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical ...
The US Food and Drug Administration (FDA) has accepted to review Iroko Pharmaceuticals New Drug Application (NDA) for lower dose submicron diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with a proposed indication of treatment ...
Tags: FDA, Pharmaceuticals, Medicine
The US Food and Drug Administration (FDA) has accepted for review AMAG Pharmaceuticals' supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for Intravenous (IV) use. The sNDA filed is to expand the indication for ...
Tags: FDA, Pharmaceuticals, oral iron treatment
India-based global pharmaceutical company Dr. Reddy's Laboratories has launched Zoledronic Acid injection (4 mg/5 mL), following the approval of its abbreviated new drug application (ANDA) from the Food and Drug Administration, in the US. ...
Tags: pharmaceutical company, pharmaceutical services, pharmaceutical
The US Food and Drug Administration (FDA) has accepted to review Antares Pharma's new drug application (NDA) of OTREXUP, designed for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis. OTREXUP ...
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
The US Food and Drug Administration (FDA) has accepted to review Sanofi's new drug application (NDA) of lixisenatide, a once-daily a glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of adults with type 2 diabetes ...
The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults. The dolutegravir new ...
Tags: infection therapy, Healthcare, FDA
The USFDA has approved Teva Pharmaceutical Industries' abbreviated new drug application (ANDA) for generic Adderall XR capsules to treat attention deficit hyperactivity disorder. The ANDA is concerned with generic version of Shire's ...
Tags: FDA, Teva Pharmaceutical Industries, ANDA, Adderall XR capsules