Biopharmaceutical company Amarin has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for the marketing and sale of its Vascepa(R) (icosapent ethyl) capsules. Vascepa is ...
Tags: Amarin, Vascepa Capsule, FDA
The USFDA has accepted for filing Astellas Pharma's supplemental new drug application (sNDA) for Tarceva (erlotinib) tablets for a genetically distinct form of advanced lung cancer. Astellas is seeking approval to use Tarceva as the ...
The FDA has approved Clinigen Healthcare's supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes. Hospira will distribute Foscavir to US ...
AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) for intravenous (IV) use of Feraheme injection, to FDA. The company is seeking approval for the label expansion of Feraheme to include all iron deficiency ...
Tags: Feraheme Injection, AMAG, SNDA
Astellas Pharma US is seeking FDA approval for Tarceva tablets to treat non-small cell lung cancer patients (NSCLC) with tumors containing epidermal growth factor receptor (EGFR) that triggers mutations. The company submitted a ...
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
The FDA has approved the stretched dose range for Sunovion Pharmaceuticals' Latuda for the treatment of patients with schizophrenia. After the review of the supplemental new drug application (sNDA), which was submitted in June 2011, ...
Tags: FDA, Schizophrenia, dose range for Latuda
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nuvo Research's Pliaglis (lidocaine/tetracaine) 7%/7% cream. Pliaglis, a topical local anesthetic cream forms a pliable peel on the skin ...
The US Food and Drug Administration(FDA)approved Actelion Pharmaceuticals'supplemental new drug application(sNDA)for second generation Veletri(epoprostenol)for injection. Veletri(epoprostenol)for injection is indicated for the treatment ...
Tags: FDA, Actelion sNDA, Actelion Pharmaceuticals, Veletri
Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult patients with depressive episodes ...
Tags: FDA, sNDA, atypical class of drugs, bipolar depression
Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA). Zytiga (abiraterone acetate) is administered in combination with ...
Tags: sNDA, priority review, FDA
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. ...
Tags: FDA, sNDA, pharmaceutical product, clinical development
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate). Janssen-Cilag International NV has also sent a type II variation to the European Medicines ...