The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml. Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is ...
Tags: FDA, Sun Pharma, Pharmaceutical
US-based biopharmaceutical company Hyperion Therapeutics has announced that it has gained approval from US Food and Drug Administration (FDA) for its RAVICTI (glycerol phenylbutyrate) liquid drug. RAVICTI used for treating Urea Cycle ...
Tags: FDA, drug, biopharmaceutical company
ScinoPharm and Foresee Pharmaceuticals have signed an agreement to form a joint venture for developing a series of peptide injectable drugs with the first being a new oncological Leuprolide injectable drug used for treating prostate cancer. ...
American pharmaceutical company BioDelivery Sciences (BDSI) has completed the safety and tolerability trial of BEMA Buprenorphine/Naloxone (BNX), which is indicated for the treatment of opioid dependent patients. BDSI claims that BNX, ...
Tags: BioDelivery Sciences, BEMA Buprenorphine, opioid dependent patients
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 ...
Inovia Pharmaceuticals will move its hepatitis C DNA vaccine into a phase 1/11a clinical trial by the end of 2013. The advancement of this work is based on exceptional results of a preclinical study, which showed for the first time that a ...
Tags: Inovia Pharmaceuticals, hepatitis C DNA vaccine, clinical trial, 2013
The US Food and Drug Administration (FDA) has approved InnoPharma's abbreviated new drug application (ANDA) for acetylcysteine injection. The acetylcysteine injection, which is a generic equivalent of Cumberland Pharmaceuticals' Acetadote ...
Tags: FDA, acetylcysteine injection, Pharmaceuticals, acetaminophen
Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) ...
Tags: Ferric Citrate, Tobacco, CKD, Pharmaceutical
Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets. Mylan ...
Tags: Medicine
US FDA has approved Watson Pharmaceuticals' abbreviated new drug application (ANDA) for Oxycodone and Acetaminophen tablets, USP 7.5 mg/500 mg and 10 mg/650 mg. The tablets are the generic equivalent to Endo Pharmaceuticals' Percocet ...
Tags: US FDA, ANDA, Watson Pharmaceuticals, Oxycodone and Acetaminophen tablets
Mylan's subsidiary Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. Phenytoin is the generic ...
Tags: Mylan, Mylan Pharmaceuticals, US, FDA, ANDA, Phenytoin Chewable Tablets
The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets. Following the ANDA approval, the company has also annonunced the immediate launch of the tablets. ...
Tags: US FDA, ANDA, Breckenridge Pharmaceutical, rizatriptan benzoate tablets
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
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 ...