News – Page 93 – Global Reach Health

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

August 29, 2019

Generic for Alimta Receives Tentative Approval

August 29, 2019 – The U.S. FDA has granted tentative approval to Mylan’s generic for Eli Lilly’s Alimta® (pemetrexed injection). The product is indicated to treat of pleural mesothelioma and non-small cell lung cancer.

August 28, 2019

Nourianz Approved to Treat Off Episodes of Parkinson’s Disease

August 28, 2019 – The U.S. FDA has approved NourianzTM (istradefylline), manufactured by Kiowa Kirin, for use as an adjunctive treatment for adults who are also taking levodopa/carbidopa, have Parkinson's disease, and are experiencing off episodes.

August 28, 2019

FDA Issues Safety Communication Regarding Use of Hepatitis C Drugs

August 28, 2019 – The U.S. FDA has received reports of rare worsening liver function or liver failure in patients with moderate to severe liver impairment who have received the following treatments for chronic hepatitis C virus (HCV)

August 26, 2019

Taltz Receives New Indication for Ankylosing Spondylitis

August 26, 2019 – The U.S. FDA has approved a new indication for Taltz® (ixekizumab), manufactured by Eli Lilly. The product is now indicated to treat adult patients who have active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).