Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...
Tags: FDA Approval, drug application
Avanir Pharmaceuticals has settled pending patent litigation concerning Sandoz's abbreviated new drug application (ANDA) to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. Under the ...
Tags: Avanir Pharmaceuticals
ANI Pharmaceuticals has signed a binding letter of intent with Sofgen Pharmaceuticals to develop and market an oral soft gel prescription product indicated for cardiovascular health. Development, manufacturing and regulatory activities of ...
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
Oral drug delivery systems developer Oramed Pharmaceuticals has submitted a pre-Investigational New Drug (pre-IND) seeking approval from the US Food and Drug Administration (FDA) to commence a trial on its orally ingestible exenatide ...
Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent
Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
Mylan Pharmaceuticals has introduced Norethindrone Tablets USP, 0.35mg, which is the generic version of Watson Laboratories' (now Actavis) Nor-Q.D. tablets, 0.35mg for 28-day cycle, for the prevention of pregnancy in the US. The ...
Tags: Generic Contraceptive Pill, Mylan
Mylan Pharmaceuticals, Mylan's US subsidiary, has launched one of the first generic versions of Abbott's Trilipix Capsule in the US. Known as Fenofibric Acid Delayed-release Capsules, 45mg and 135mg is indicated for patients with mixed ...
The USFDA has cleared Actavis' abbreviated new drug application (ANDA) for Lamotrigine orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg. A generic version of GlaxoSmithKline's Lamictal ODT, the antiepileptic drug is indicated ...
Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER. Oxymorphone Hydrochloride extended-release tablets, which is available in ...
Tags: FDA, ANDA, Generic Opana ER