Aranya Tomseth » Blog Archive » Recent New Drug Applications

June3

Here are the most recent drug applications submitted to the FDA for approval. I always find it interesting to see what’s coming our way.

Sancuso (granisetron) Transdermal Patch Company: ProStrakan Group; Treatment for: Nausea/Vomiting - Chemotherapy Induced. Sancuso (granisetron) is an anti-emetic transdermal delivery system in development for the treatment of chemotherapy-induced nausea and vomiting without the need for injections or swallowing pills.

Promacta (eltrombopag): Company: GlaxoSmithKline; Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura. Promacta (eltrombopag) is an investigational oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.

Liraglutide Company: Novo Nordisk; Treatment for: Diabetes Mellitus Type II. Liraglutide is a once-daily human GLP-1 analogue in development for the treatment of people with type 2 diabete

Rezonic (casopitant): Company: GlaxoSmithKline; Treatment for: Nausea/Vomiting - Chemotherapy Induced, Nausea/Vomiting - Postoperative. Rezonic (casopitant) is an investigational NK-1 receptor antagonist in development as add-on therapy for the prevention of chemotherapy-induced nausea and vomiting, and also for the prevention of postoperative nausea and vomiting.

Surfaxin (lucinactant). Company: Discovery Laboratories, Inc. Treatment for: Respiratory Distress Syndrome. Surfaxin, an engineered version of natural human lung surfactant, represents a potential alternative to the commercially available animal-derived surfactants used for the prevention of Respiratory Distress Syndrome in premature infants.

OTG (oxybutynin hydrochloride) Topical Gel. Company: Watson Pharmaceuticals, Inc. Treatment for: Overactive Bladder

Viviant (bazedoxifene). Company: Wyeth Pharmaceuticals. Treatment for: Prevention of Osteoporosis. Viviant (bazedoxifene) is a selective estrogen receptor modulator (SERM) in development for the prevention of postmenopausal osteoporosis.

Davanat Company: Pro-Pharmaceuticals, Inc. Treatment for: Targeted Drug Delivery. Davanat is a polysaccharide polymer comprised of mannnose and galactose in development for the targeted delivery of drugs used in the treatment of cancer.

Reloxin (botulinum toxin type A) Company: Ipsen and Medicis. Treatment for: Aesthetics. Reloxin (botulinum toxin type A) is a neurotoxin in development for the temporary improvement in the appearance of some facial wrinkles.

Iclaprim Intravenous Injection. Company: Arpida Ltd. Treatment for: Skin and Structure Infection. Iclaprim is a broad-spectrum diaminopyrimidine antibiotic in development for the treatment of complicated skin and skin structure infections.

Sublinox (zolpidem) Sublingual Tablets. Company: Orexo and Meda AB. Sublinox is a sublingual tablet formulation of the widely used drug zolpidem. Sublinox is being developed to provide fast, effective absorption for the short term treatment of insomnia.

Entereg (alvimopan) Capsules. Company: Adolor Corporation. Treatment for: Postoperative Ileus. Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

Cinryze (C1 inhibitor). Company: Lev Pharmaceuticals, Inc. Treatment for: Angioedema. Cinryze is a C1-esterase inhibitor being developed as a comprehensive replacement therapy for the treatment of hereditary angioedema (HAE).

Naturlose (tagatose). Company: Spherix Incorporated. Treatment for: Diabetes Mellitus Type II. Naturlose (tagatose) is a unique sugar undergoing clinical trials as a treatment for Type 2 diabetes.

Imagify (perflubutane). Company: Acusphere Inc. Imagify is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.

MK-0524A (niacin ER and laropiprant) - formerly Cordaptive. Company: Merck & Co., Inc. Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hypertriglyceridemia. MK-0524A is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. MK-0524A is used either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.