Pharma News

Lannett Company, Inc. announced that its strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil's chronic pain treatment Duragesic®. 

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AveXis, Inc., a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for AVXS-101, the company’s lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients.  

The European Medicines Agency (EMA) has accepted for review, Mylan’s Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). 

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The U.S. Food and Drug Administration has approved an expanded indication for Synjardy^® (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). SYNJARDY, from Boehringer Ingelheim and Eli Lilly and Company, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.

Cerulean Pharma, a clinical-stage company developing nanoparticle-drug conjugates (NDCs), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Cerulean's lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer.

Allergan plc  and Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC^® (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).

Ajanta Pharma Limited received final approval from US FDA and launched Omeprazole and Sodium Bicarbonate Capsules in the US market, through its wholly owned subsidiary Ajanta Pharma USA Inc.

U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for a 500mg chewable tablet formulation of mebendazole from Janssen Pharmaceuticals.

For HIV-infected mothers whose immune system is in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants, according to results from a large clinical trial conducted in sub-Saharan Africa and India