Pharmaceutical – Global Reach Health

October 2, 2019

NDMA Identified in OTC and Prescription Ranitidine

October 2, 2019 – The U.S. FDA has become aware that some products containing ranitidine, the active ingredient in Zantac®, contain low levels of N-itrosodimethylamine (NDMA), a probable human carcinogen (cancer-causing agent). NDMA is a known environmental contaminant found in water and food such as meats, dairy products, and vegetables.

September 20, 2019

Rybelsus Approved As Novel Treatment for Diabetes

September 20, 2019 – The U.S. FDA has approved Rybelsus® (semaglutide) oral tablets, manufactured by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Rybelsus is the first FDA-approved glucagon-like peptide-1 (GLP-1) receptor agonist with an oral route of administration.

September 19, 2019

New Indication Approved for Pifeltro and Delstrigo

September 19, 2019 – The U.S. FDA has approved a new indication for PifeltroTM (doravirine) tablets and DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets, both manufactured by Merck. They are now approved for use in combination with other antiretroviral medicines to replace the current antiretroviral

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.