Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
Mylan Pharmaceuticals, the subsidiary of Mylan, has introduced Fenofibrate tablets, 48 mg and 145 mg. The company has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application ...
Tags: Mylan, Generic Version
TaiGen Biotechnology has submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Nemonoxacin is the first ...
Tags: TaiGen Biotechnology, Medicine
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg. The generic equivalent of IPR Pharmaceuticals' Zomig tablets is indicated for the acute treatment of migraine ...
Tags: FDA, Pharmaceuticals
Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg. The central ...
Tags: TWi, FDA, pharmaceutical
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
Actavis has resolved outstanding patent litigation concerning generic version of Intuniv (guanfacine hydrochloride), indicated for the treatment of attention deficit hyperactivity disorder, with Shire. The settlement agreement also ...
GSK and Theravance have announced the submission of a regulatory application for Anoro Ellipta (UMEC/VI) (62.5/25mcg and 125/25mcg doses) in Japan. UMEC/VI combines a long-acting muscarinic antagonist (LAMA) GSK573719 or umeclidinium ...
The USFDA has approved Amarin supplemental new drug application for Chemport as additional Vascepa active pharmaceutical ingredient supplier. The approval adds to the company's planned expansion of the Vascepa manufacturing supply chain ...
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Allergan's New Drug Application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. In addition ...
Tags: Migraine Therapy, Medicine
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg. The company has begun the shipment of the product ...
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%. Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International. Mylan ...
Tags: FDA, Acyclovir Ointment, Medicine
The US FDA has approved Teva Pharmaceutical Industries' new drug application (NDA) for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets as oral contraceptives. Quartette, designed as next generation of extended ...
Tags: Health, Medicine, oral contraceptives