US Food and Drug Administration (FDA) has approved Reckitt Benckiser Pharmaceuticals's Suboxone (buprenorphine and naloxone) sublingual film 4 mg and 12 mg doses. Suboxone is an office-based treatment used to treat opioid dependence, ...
Tags: Suboxone Tablets, office-based treatment, opioid dependence
Wockhardt, a pharmaceutical and biotechnology company, has received final FDA approval for marketing 100mg, 150mg and 200mg 12 hour extended release tablets of Bupropion HCl indicated for depression. Wockhardt has announced the immediate ...
Watson Pharmaceuticals has introduced Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets, a generic equivalent to Actos. The company began the shipment of the product after winning the final FDA approval. Actos is a prescription ...
Tags: Generic Version, Actos, blood sugar
Meridian Medical Technologies,a Pfizer subsidiary,and Teva have entered into a settlement agreement to resolve generic epinephrine auto-injector pending patent litigation. Under the terms of the agreement,Teva may launch a generic ...
Tags: Epinephrine Auto, Meridian, Teva, generic epinephrine auto-injector
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
Royer Biomedical(RBI)wins FDA approval to progress human testing of AppliGel-G(Gentamicin)in management of diabetic foot ulcers(DFU). The patented proprietary dissolvable non-immunogenic polymer drug delivery system platform has ...
Capstone Therapeutics and LipimetiX have formed LipimetiX Development , a joint venture (JV), to develop drugs that are used to treat indications of lowering blood cholesterol levels. The JV will develop a family of Apo E mimetic peptides ...
Tags: Apolipoprotein E, lipoprotein metabolism, Capstone Therapeutics
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 ...
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 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 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
GlaxoSmithKline's (GSK) Promacta has won FDA approval as thrombocytopenia therapy in chronic hepatitis C patients. Promacta, brand name of eltrombopag in the US, will enable thrombocytopenia patients suffering from chronic hepatitis C ...
Tags: FDA approval, thrombocytopenia therapy, chronic hepatitis C