Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
The FDA has approved the stretched dose range for Sunovion Pharmaceuticals' Latuda for the treatment of patients with schizophrenia. After the review of the supplemental new drug application (sNDA), which was submitted in June 2011, ...
Tags: FDA, Schizophrenia, dose range for Latuda
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Nevirapine Tablets USP, 200mg and initiated the shipment of the product. The generic version of Boehringer Ingelheim's Viramune is ...
Tags: Mylan pharmaceuticals, ANDA, ARV
Mylan's subsidiary, Mylan Pharmaceuticals, has settled Provigil litigation with Teva Pharmaceutical USA. The settlement follows the Mylan litiagtion against the US Food and Drug Administration (FDA) regarding Mylan's abbreviated new drug ...
AVEO Oncology and Astellas Pharma have announced FDA acceptance of tivozanib new drug application(NDA)filing for the treatment of advanced renal cell carcinoma(RCC). According to the development and commercialization deal signed between ...
Tags: AVEO Oncology, Astellas Pharma, FDA, RCC, NDA
Mylan Institutional business has won final FDA approval for its abbreviated new drug application (ANDA) for preservative-free Thiamine Hydrochloride Injection, 100mg/ml, packaged in 200mg/2ml multiple-dose vials. Mylan is shipping the ...
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nuvo Research's Pliaglis (lidocaine/tetracaine) 7%/7% cream. Pliaglis, a topical local anesthetic cream forms a pliable peel on the skin ...
Perrigo Company has received final FDA approval for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac gel. Duac Gel is indicated for the ...
Tags: perrigo company, ANDA, patent litigation
Mylan Pharmaceuticals has received final FDA approval for its abbreviated new drug application (ANDA) for Lithium Carbonate Extended-release tablets USP, 300mg. Mylan has announced immediate shipment of the generic version of Noven ...
Tags: new drug, Lithium Carbonate Extended-release tablets USP, manic episodes
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) for Pioglitazone tablets USP, 15mg, 30mg and 45mg. Previously, FDA has also approved the company's ANDA for Pioglitazone Hydrochloride and ...
Mylan Pharmaceuticals has introduced the generic version of Schering-Plough's Clarinex allergy medication, Desloratadine tablets, 5mg. Mylan gained final FDA approval for its abbreviated new drug application for Desloratadine Tablets, ...
Tags: Generic Clarinex Tablets, Desloratadine tablets, drug applications
Mylan and its subsidiary, Mylan Pharmaceuticals, have signed a settlement agreement with Pfizer, Pharmacia & Upjohn Company and Pfizer Health related to Detrol LA patent litigation. The litigation is related to Mylan Pharmaceuticals' ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application for Olanzapine tablets USP, 2.5mg, 5mg, 7.5mg, 10mg, 15mg, and 20mg. The company begins the shipment of the product, which is the generic equivalent ...
Tags: Generic Zyprexa Tablets, Mylan Pharmaceuticals, new drug
APP Pharmaceuticals, a Fresenius Kabi Company, has purchased three products, Benztropine Mesylate Injection, Levetiracetam Injection and Tranexamic Acid Injection, from Nexus Pharmaceuticals. As per the agreement, APP acquires complete ...
The FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Clopidogrel tablets USP, 75mg and 300mg. The generic version of Sanofi-Aventis' Plavix is indicated for acute coronary syndrome and for patients with ...
Tags: Clopidogrel Tablets, Mylan Pharmaceuticals, drug application