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
Dr. Reddy's Laboratories, an integrated global pharmaceutical company, has introduced Ibandronate Sodium tablets (150mg) in the US, following FDA approval of the product's ANDA. The product, Ibandronate Sodium tablets (150mg), is the ...
Tags: ibandronate sodium tablets, Boniva, Dr.Reddy's Laboratories
Nectid, a drug discovery company, has initiated clinical development of agomelatine for autism and pain indications in the US. Agomelatine, a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist, is approved for the ...
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 ...
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' ...
ProMetic Life Sciences and NantPharma have together formed an affiliate company, NantPro BioSciences, to develop and commercialize a plasma-derived biopharmaceutical product for the US market. The new US based company has entered into ...
Tags: affiliate company, plasma-derived biopharmaceutical product
Mobius Therapeutics, an ophthalmic company, has begun commercial shipments of Mitosol (mitomycin for solution) kit for ophthalmic use. Mitosol will provide a new system for delivering a precise dose of its active ingredient, mitomycin-c, ...
Onyx Pharmaceuticals, a licensee of Ligand Pharmaceuticals, has gained FDA approval for Kyprolis (carfilzomib) for injection. Kyprolis is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have ...
Tags: Onyx Pharmaceuticals, Ligand Pharmaceuticals, Kyprolis
Forest Laboratories and Adamas Pharmaceuticals have collaborated for the development of a fixed dosed combination (FDC) of Namenda XR and donepezil HCl for Alzheimer's dementia in the US. The company expects to launch the FDC that will be ...
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
Pfizer and Protalix BioTherapeutics have announced FDA approval of Elelyso (taliglucerase alfa) for injection to treat type 1 Gaucher disease. Elelyso, derived from ProCellEx, is an enzyme replacement therapy (ERT) for the long-term ...
Tags: Protalix/Pfizer Gaucher Drug, Pfizer and Protalix BioTherapeutics