Industry News

Janssen Biotech, Inc., announced that the U.S. Food and Drug Administration (FDA) has  approved STELARA ® (ustekinumab) for the treatment of moderately to severely active  Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment  with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis  factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF  blockers. STELARA ® is the first biologic therapy for Crohn’s disease targeting interleukin  (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. 

Leading the way in becoming an inspirational model for pharmaceutical sector, Gujarat has evolved into a hub for major pharmaceutical companies. Many investment-friendly initiatives and growth propelling policies in industries such as pharmaceutical & biotechnology, textile, auto, gems & jewellery, IT, maritime & port and engineering are significantly driving growth for the state.

Marksans Pharma Limited announces that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) for Loratadine Liquid Filled Capsules 10 mg.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

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Allergan plc announced the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive breast implants, offering women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and Allergan's highly cohesive gel for a customized result. The new NATRELLE INSPIRA® Cohesive line of breast implants is the newest entry into the category of breast implants commonly referred to  as "gummy" implants, designed for women who are interested in increased breast fullness.

Allergan plc and Adamas Pharmaceuticals, Inc announced that all four dosage strengths of NAMZARIC® (memantine and donepezil hydrochlorides) extended-release capsules that allow patients on donepezil 10 mg to start directly on NAMZARIC are now available by prescription in pharmacies throughout the U.S. NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI) for the treatment of moderate to severe Alzheimer's Disease in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC'S new indication and dosage strengths were approved by the U.S. Food and Drug Administration (FDA) in July 2016.

The U.S. Food and Drug Administration  approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Janssen Pharmaceuticals, Inc. (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR—a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)—for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. INVOKAMET® XR combines INVOKANA® (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since launch, and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.