MYLAN: Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

Mylan N.V. (NASDAQ: MYL) announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials. Read More »

PANTHERX® RARE PHARMACY: Selected by Ultragenyx Pharmaceutical to Distribute DOJOLVI™ (triheptanoin), for Patients with Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)

PANTHERx® Rare Pharmacy announces that it has been selected by Ultragenyx Pharmaceutical as a limited distribution partner for new drug DOJOLVI™ (triheptanoin). DOJOLVI™ (a highly purified, pharmaceutical-grade, synthetic seven carbon fatty acid triglyceride) is a specially designed synthetic triglyceride compound, which was developed to treat patients with long-chain fatty acid oxidation disorders (LC-FAOD). Read More »

MYLAN INC: Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)

Wixela™ Inhub™ is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD) Read More »

MYLAN N.V.: Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Read More »