GlobalReach Health – Page 95 – Global Reach Health

September 12, 2019

Ibsrela Approved to Treat Irritable Bowel Syndrome

September 12, 2019 – The U.S. FDA has approved Ibsrela® (tenapanor), manufactured by Ardelyx, to treat irritable bowel syndrome with constipation (IBS-C) in adults. A novel, minimally absorbed small molecule, Ibsrela acts locally in the gastrointestinal (GI) tract.

September 12, 2019

Nucala Receives Expanded Indication

September 12, 2019 – The U.S. FDA has approved an expanded indication for Nucala® (mepolizumab), manufactured by GlaxoSmithKline. The product is now indicated for use as an add-on maintenance treatment for children who are at least six years of age and have severe eosinophilic asthma. It was previously approved only for children 12 years old and up.

September 10, 2019

Aczone Gel Receives Expanded Approval

September 10, 2019 – The U.S. FDA has approved an expanded indication for Aczone® 7.5% Gel, manufactured by Almirall LLC. The product is now indicated for use as a topical treatment for inflammatory and non-inflammatory patients in patients who are least nine years of age.

September 10, 2019

Gvoke Approved to Treat Hypoglycemia

September 10, 2019 – The U.S. FDA has approved GvokeTM (glucagon) injection, manufactured by Xeris Pharmaceuticals. It is the first ready-to-use, shelf-stable liquid glucagon to receive FDA approval, and is indicated to treat severe hypoglycemia in adult and pediatric patients who are at least two years old and have diabetes.

September 6, 2019

Generic Amicar Approved

September 6, 2019 – The U.S. FDA has approved Amneal Pharmaceuticals' generic for Akorn’s Amicar® (aminocaproic acid) 0.25g/mL oral solution. The product was approved under the FDA's Competitive Generic Therapy (CGT) program, which is designed to accelerate review of generics for drugs that lack sufficient generic competition.

September 6, 2019

Authorized Generics for NovoLog and NovoLog Mix Announced

September 6, 2019 – Novo Nordisk has announced its intention to launch authorized generics for NovoLog® (insulin aspart injection) and NovoLog® Mix (insulin aspart protamine/insulin aspart) products. NovoLog and NovoLog Mix products are indicated to improve glycemic control in patients who have diabetes mellitus.

September 6, 2019

Natpara Recalled

September 6, 2019 – Takeda Pharmaceuticals has voluntarily recalled all doses of Natpara® (parathyroid hormone) for injection due to the potential for rubber particles to break off from the rubber septum of the Natpara cartridge.

September 6, 2019

Ofev Granted New Indication to Treat Interstitial Lung Disease

September 6, 2019 – The U.S. FDA has approved a new indication for Ofev® (nintedanib), manufactured by Boehringer Ingelheim, to slow the rate of decline in pulmonary function in patients who have systemic-sclerosis-associated interstitial lung disease (SSc-ILD). It is the first drug to receive FDA-approval for this indication.