Mylan N.V. announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
GSK announced that dosing has commenced in a phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA).
In a setback to Cipla, the Delhi High Court on Friday held that the Indian drug major was infringing Swiss pharmaceutical company Hoffman-La Roche's patent in lung cancer drug erlotinib hydrochloride, sold under the name of Tarceva.
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a once-weekly pill.
Novartis announced that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
Mylan N.V. announced the U.S. launch of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (mixed salts of a single entity amphetamine product), 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, which is the generic version of Teva's Adderall® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
GSK announced that the European Commission has approved a variation to expand the current therapeutic indication for Volibris® (ambrisentan) to include its use in combination treatment for patients with pulmonary arterial hypertension (PAH). Volibris is indicated for treatment of PAH in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.
The U.S. Food and Drug Administration approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Portrazza is marketed by Eli Lilly and Company, based in Indianapolis, Indiana.
The U.S. Food and Drug Administration approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.
The injectable drug has been hailed as the first meaningful advance in treating haemophilia A in 20 years, and looks set to be a big earner for the partners. Elocta – a recombinant factor VIII Fc fusion protein (rFVIIIFc) – is already launched in the US, Canada and Australia under the Eloctate trade name, and is forecast to reach peak sales of $1.5 billion thanks to patient-friendly dosing that increases the time between injections.
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
Also Join: 
.png)
