Pharmaceutical News – Page 16 – Global Reach Health

September 17, 2019

Keytruda and Lenvima Approved to Treat Endometrial Cancer

September 17, 2019 – The U.S. FDA has announced the first drug approval granted through Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. Through the program, the FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada granted

September 17, 2019

Erleada Receives New Indication

September 17, 2019 – The U.S. FDA has approved a new indication for Erleada® (apalutamide), manufactured by Janssen Pharmaceuticals. The product is now indicated to treat metastatic castration-sensitive prostate cancer (mCSPC).

September 13, 2019

FDA Issues Safety Communication for Ibrance, Kisqali, and Verzenio

September 13, 2019 – The U.S. FDA has warned that Ibrance® (palbociclib – Pfizer), Kisqali® (ribociclib – Novartis), and Verzenio® (abemaciclib – Eli Lilly) may cause rare but severe inflammation of the lungs in some patients being treated for advanced breast cancer. As a result, the agency is requiring new warnings be added to the prescribing information

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.