Wockhardt has received final approval from the US Food and Drug Administration ((FDA) to market extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used to treat hypertension. Felodipine is the generic name for ...
GI medical devices developer Given Imaging has submitted an application to US Food and Drug Administration(FDA)seeking approval to use its non-invasive imaging tool for visualization of the lower gastrointestinal tract. The PillCam Colon ...
Tags: PillCam Colon 2 capsule endoscopy system, Given Imaging
Ipsen has avoided an interruption in US supply of Increlex (IGF-1) to treat Severe Primary IGF-1 Deficiency due to delays in manufacturing site approval. Ipsen has worked in close relation with the US Food and Drug Administration to ...
Tags: Ipsen, Increlex Supply, Severe Primary IGF-1 Deficiency
Teva Pharmaceutical has received US Food and Drug Administration(FDA)approval for Synribo injection to treat adult patients with chronic phase(CP)or accelerated phase(AP)chronic myeloid leukemia(CML)with resistance and/or intolerance to ...
Tags: Teva Synribo Injection, US FDA, Teva Pharmaceutical, chronic phase
Onco Therapies,a wholly owned subsidiary of Strides Arcolab,has received US Food and Drug Administration approval for Cisplatin injection. Cisplatin is a chemotherapy drug used to treat various types of cancers,including ...
Tags: Onco Therapies, Strides Arcolab, Cisplatin injection, chemotherapy drug
The US Food and Drug Administration(FDA)has granted 510(k)clearance to AtCor Medical's new blood pressure cuff-based system,designed for measuring brachial and central aortic blood pressure simultaneously. Available in ...
The US Food and Drug Administration(FDA)has granted orphan drug designation to Savara Pharmaceuticals'first inhaled antibiotic,designed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus(MRSA)infection in cystic ...
Tags: Orphan Drug, Savara Pharma, FDA, inhaled antibiotic, MRSA
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 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 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
The US Food and Drug Administration (FDA) has granted 510(k) approval to Teleflex Incorporated's ArrowADVANTAGE5 non-coated pressure-injectable peripherally inserted central catheter (PICC) for central venous pressure (CVP) monitoring ...
Tags: pressure-injectable, central venous pressure, CVP, central catheter
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Masimo's new uSpO2 universal pulse oximetry cable for use with GE Healthcare's patient-worn monitors in ambulatory patient care environments. The uSpO2 cable is an ...
Tags: pulse oximetry cable, patient care environments, pulse oximetry device