The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
The FDA has approved Stiefel's new drug application (NDA) for Fabior (tazarotene) foam, 0.1%, to treat acne vulgaris in patients 12 years of age and older. North America Dermatology vice president Jean-Christophe May said, "Stiefel is ...
Tags: Stiefel NDA, Tazarotene foam, Medicine
The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
The US Food and Drug Administration's (FDA) Center For Drug Evaluation and Research has issued new guidelines for the packaging of test batches manufactured for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications ...
Tags: FDA, food, drug, packaging, test batches, ANDA, labeling
ArQule and Daiichi Sankyo have signed a special protocol assessment (SPA) agreement with the FDA for Phase 3 trial of Tivantinib in hepatocellular carcinoma (HCC). The SPA process enables FDA to offer official evaluation and written ...
Tags: ArQule, Daiichi Sankyo, SPA, FDA
Mylan Pharmaceuticals has won FDA approval for its abbreviated new drug application (ANDA) for Irbesartan Tablets USP, 75mg, 150mg and 300mg, the generic version of Sanofi's Avapro. The FDA has also approved the company's ANDA for ...
Tags: FDA approval, ANDA, Irbesartan Tablets
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
The United States Patent Office has issued a patent covering Nuvo Research's compositions and methods of using Pennsaid (diclofenac sodium topical solution) 2.0% w/w (Pennsaid 2% Patent), which will expire on 21 April 2028. Pennsaid is a ...
Results are interesting for treating skin cancer(melanoma)and nervous system tumors,known as gliomas. "Promising results"-Pablo Botella,researcher at the Institute of Chemical Technology of Valencia. Spanish researchers have ...
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 USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm. Lidocaine is an amide-type local anesthetic agent and is suggested to ...
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
Apexigen, a biopharmaceutical company, has announced the filing of investigational new drug (IND) application for APX001, also known as SSS07, by its partner 3SBio [SSRX] of Shenyang, China. With the IND approval, APX001/SSS07 will be ...
Tags: IND approval, clinical trials, autoimmune diseases, inflammatory diseases
The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) of Modafinil tablets USP,100 mg and 200 mg. Modafinil USP,100 mg and 200 mg tablets are generic ...
Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. The approved ...
Tags: Medicine, Etomidate Injection, Hospira's Amidate injection