Eli Lilly and Company Alimta(pemetrexed for injection)has received FDA approval for new use in the continuation maintenance setting for advanced or metastatic nonsquamous non-small cell lung cancer(NS NSCLC). The approval was based on ...
Sunovion Pharmaceuticals has launched Zetonna(ciclesonide)Nasal Aerosol,74 mcg once-daily,in the US,which is used to treat allergic rhinitis(AR),also known as hay fever or nasal allergies. Zetonna is also used to treat symptoms ...
The US Food and Drug Administration(FDA)approved Actelion Pharmaceuticals'supplemental new drug application(sNDA)for second generation Veletri(epoprostenol)for injection. Veletri(epoprostenol)for injection is indicated for the treatment ...
Tags: FDA, Actelion sNDA, Actelion Pharmaceuticals, Veletri
Specialty pharmaceutical company Intelliject has received the US Food and Drug Administration(FDA)approval for its Auvi-Q(epinephrine injection,USP)used in the emergency treatment of life-threatening allergic reactions in people who are at ...
Tags: Specialty pharmaceutical company, Auvi-Q, Spencer Williamson, FDA
The Bracco Diagnostics has gained FDA approval for the use of MultiHance(gadobenate dimeglumine)injection,529mg/ml,in magnetic resonance angiography(MRA)to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive ...
Watson Laboratories,a subsidiary of Watson Pharmaceuticals,has won FDA approval for its abbreviated new drug application(ANDA)for Budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL unit-dose ampoules. Budesonide Inhalation ...
Sun Pharmaceutical Industries has received FDA approval for its abbreviated new drug application (ANDA) of Azelastine HCL nasal spray, 0.1% (137mcg/spray). The generic equivalent to Medpointe Pharm's Astelin nasal spray is indicated to ...
Tags: Sun Pharmaceutical Industries, Azelastine HCL nasal spray, Medicine
Mylan has reached a settlement in a patent litigation suit filed by Sunovion Pharmaceuticals concerning Mylan Specialty's abbreviated new drug application for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31mg/3 mL, 0.63mg/3 mL, ...
Tags: Sunovion Pharmaceuticals, Medicine
Mylan Laboratories, formerly Matrix Laboratories, has gained final FDA approval for its abbreviated new drug application (ANDA) of Atorvastatin Calcium Tablets of strengths 10mg, 20mg, 40mg and 80mg. The company begins immediate shipment ...
Tags: Generic Lipitor Anda, drug application, Atorvastatin Calcium Tablets
The USFDA has approved ThromboGenics'Jetrea(ocriplasmin)for the treatment of symptomatic vitreomacular adhesion(VMA). The approval was based on the Phase III trial data which demonstrated that Jetrea is superior to placebo for the ...
Tags: ThromboGenics'Jetrea, symptomatic vitreomacular adhesion, USFDA
The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
The Anti-Infective Drugs Advisory Committee to the US Food and Drug Administration (FDA) has supported the clinical benefit of GlaxoSmithKline's raxibacumab to treat inhalational anthrax. In addition, the committee also favoured the ...
Tags: The Anti-Infective Drugs, raxibacumab anti-toxin development programme
The FDA has approved Stiefel's new drug application (NDA) for Fabior (tazarotene) foam, 0.1%, to treat acne vulgaris in patients 12 years of age and older. North America Dermatology vice president Jean-Christophe May said, "Stiefel is ...
Tags: Stiefel NDA, Tazarotene foam, Medicine
Cardium Therapeutics and its Tissue Repair Company, Cardium, will utilize AMRI's Burlington, US, site to manufacture sterile pre-filled syringes in support of the US introduction of Excellagen, as per the signed contract agreement. ...
Tags: Cardium Therapeutics, syringe-based, pre-filled syringes
The US Food and Drug Administration (FDA) has granted approval to Cohera Medical's first module of its premarket approval (PMA) application for an internal surgical adhesive. The CE marked internal adhesive, TissuGlu, is designed for ...
Tags: internal surgical adhesive, adhesive, Medical's module