Pharmaceutical News – Page 17 – Global Reach Health

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.

September 6, 2019

U.S. FDA Stresses Importance of MMR Vaccination

September 6, 2019 – In a brief statement, the U.S. FDA has again encouraged the public to take steps to prevent the measles, mumps, and rubella by following appropriate vaccination schedules for the MMR vaccine.

September 5, 2019

New Dosage Form and Expanded Indications for Harvoni

September 5, 2019 – The U.S. FDA has approved oral pellet dosage forms for Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir), manufactured by Gilead. The FDA has also granted an extended pediatric indication to each product.

September 4, 2019

Orfadin Generic Approved

September 4, 2019 – The U.S. FDA has approved a Novitium Pharma’s generic version of Sobi’s Orfadin® (nitisinone) capsules. Nitisinone capsules are indicated for use in combination with dietary restriction of tyrosine and phenylalanine to treat adult and pediatric patients who have hereditary tyrosinemia type 1 (HT-1).

September 3, 2019

Noxafil Generic Launched

September 3, 2019 – Endo Pharmaceuticals has announced the launch of its authorized generic for Merck's Noxafil® (posaconazole) 100mg delayed-release tablets. The generic received FDA approval in August 2019, and is indicated to prevent invasive Aspergillus and Candida infections in patients who are at high risk

August 30, 2019

AmEx Pharmacy Voluntarily Recalls Bevacizumab

August 30, 2019 – Pacifico National, doing business as AmEx Pharmacy, has announced the voluntary recall of all lots of Bevacizumab 1.25mg/0.05ml 31g Injectable and all lots of Bevacizumab 2.5mg/0.1ml Norm-Ject TB Injectable that are within expiry to the healthcare provider level. The products have been recalled out of