New Drug Application News and Research

RSS

Mylan receives tentative FDA approval for Topiramate capsules

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules, 15 mg and 25 mg.

11 Sep 2007

FDA warns Melanocorp for illegal sale of Melanotan II

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site.

5 Sep 2007

FDA approves Acambis smallpox vaccine

Acambis plc (Acambis) has announced that the US Food and Drug Administration (FDA) has approved its ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for protection against smallpox.

4 Sep 2007

Abbott and AstraZeneca confirm Phase III clinical trials of Fenofibrate ABT-335 and Crestor as fixed-dose combination

Abbott and AstraZeneca confirmed they will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's CRESTOR (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials.

3 Sep 2007

Indevus submits new drug application for NEBIDO

Indevus Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism.

29 Aug 2007

FDA approves new Roche direct detection of West Nile Virus in donated human blood

Roche Diagnostics announced that the US Food & Drug Administration (FDA) has approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.

From Roche Sequencing and Life Science 29 Aug 2007

FDA grants orphan drug designation to TREANDA

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's investigational therapy, TREANDA (bendamustine HCl), for the treatment of chronic lymphocytic leukemia (CLL).

29 Aug 2007

IDM Pharma receives not approvable letter for Mifamurtide for treatment of osteosarcoma

IDM Pharma, Inc. ( NASDAQ:IDMI ) announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

28 Aug 2007

Watson Pharmaceuticals receives FDA approval for generic Duragesic

Watson Pharmaceuticals, Inc. announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for fentanyl transdermal system in the 25, 50, 75 & 100 mcg/hour strengths.

21 Aug 2007

Roche files investigational new drug application for second Genmab antibody

Genmab A/S has announced that its partner Roche has filed an Investigational New Drug application (IND) with the US Food and Drug Administration for a Genmab antibody developed under the companies' collaboration.

13 Aug 2007

Mylan receives FDA approval for Verapamil Hydrochloride capsules

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Verapamil Hydrochloride (HCl) Extended-release (ER) Capsules (PM), 100 mg, 200 mg and 300 mg.

13 Aug 2007

Innovative gene therapy research for muscular dystrophy

A major grant of approximately $10 million from the National Institutes of Health will help investigators at Columbus Children's Research Institute (CCRI) at Columbus Children's Hospital learn more about strategies to treat muscular dystrophy, potentially leading to two new gene therapy approaches.

3 Aug 2007

CDC to provide intravenous artesunate for treatment of severe malaria

The Centers for Disease Control and Prevention (CDC) has received permission from the Food and Drug Administration (FDA) to provide intravenous artesunate for emergency use in the United States for persons with severe malaria.

3 Aug 2007

Court rules in favor of Sandoz on Toprol Xl patent

Sandoz was pleased to learn this week that the U.S. Court of Appeals in St. Louis has affirmed a summary judgment by U.S. District Judge Rodney Sippel invalidating patent protection on Toprol XL(R), a beta blocker used to treat angina, heart failure, and high blood pressure.

26 Jul 2007

Barr confirms patent challenge of TEMODAR

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed for Schering Corporation's TEMODAR (Temozolomide) 5mg, 20mg, 100mg & 250mg capsules.

25 Jul 2007

IDM Pharma plans to amend NDA for Mifamurtide (L-MTP-PE) for the treatment of osteosarcoma

IDM Pharma, Inc. has announced that it has recently met with the U.S. Food and Drug Administration (FDA) and informed the FDA that the Company intends to take immediate action to supplement the data in its current New Drug Application (NDA) for mifamurtide (L-MTP-PE), formerly known as Junovan, which is being reviewed for the treatment of children and adolescents with non-metastatic osteosarcoma.

23 Jul 2007

Tibotec Pharmaceuticals submits NDA for investigational HIV treatment

Tibotec Pharmaceuticals Ltd. has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for TMC125 (etravirine), an investigational non- nucleoside reverse transcriptase inhibitor (NNRTI), being studied for use with other antiretroviral (ARV) agents as a treatment for people infected with HIV- 1.

19 Jul 2007

Lupin receives approval for Amlodipine tablets

Lupin Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

18 Jul 2007

FDA approves Extina for seborrheic dermatitis

Stiefel Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis.

18 Jul 2007

Barr confirms Xopenex patent challenge

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sepracor Inc. in connection with its Xopenex (Levalbuterol Hydrochloride) 0.31mg/3mL, 0.63mg/3mL and 1.25mg/3mL.

17 Jul 2007