Aldagen receives orphan drug status for ALD-101

Aldagen, Inc announced that it has received orphan drug designation for ALD-101 from the US Food and Drug Administration (FDA). The designation was granted for the use of ALD-101 to improve patient outcomes by decreasing time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.

The details can be read here.

Stride Arcolab gets US FDA nod for pamidronate injection

Stride Arcolab has received US FDA approval for pamidronate disodium injection, 3mg/ml and 9mg/ml for single use vials. The product is licensed to Akorn-Strides, LLC, which is a joint venture that was formed in 2004 by Akorn Inc and Strides.

The details can be read here.

Sanvar (Debio 8609) for Esophageal Variceal Bleeding

Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that Debiovision Inc., its Canadian affiliate, filed its Complete Response to the approvable letter received from the United States (U.S.) Food and Drug Administration (FDA) for Sanvar(R), or Debio 8609 (vapreotide acetate). The immediate release formulation of Sanvar(R), a somatostatin analogue, is used in the treatment of acute esophageal variceal bleeding (EVB).

The details can be read here.

FDA Approves Additional Indication for Norditropin for Small for Gestational Age (SGA) in Children

Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years.

The details can be read here.

Sanusco, the First and Only Patch for Preventing Nausea and Vomiting in Chemotherapy Patients, Now Available

ProStrakan Group plc today announced that SANCUSO(R) (Granisetron Transdermal System) is now available by prescription for patients with chemotherapy-induced nausea and vomiting (CINV) in the United States. Sancuso was approved by the U.S. Food and Drug Administration (F.D.A.) in September 2008 as the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.

The details can be read here.

Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra and Launches Immediately

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra(R).

The details can be read here.

US FDA approves new indication for Hospira's Precedex

Hospira, Inc, a global specialty pharmaceutical and medication delivery company, announced that the US Food and Drug Administration (FDA) approved a new indication for Precedex (Dexmedetomidine Hydrochloride Injection), the company's innovative drug for in-hospital sedation. This approval allows for use of Precedex in non-intubated patients requiring sedation prior to and/or during surgical and other procedures.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter

On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. received a warning letter from the FDA. The letter was issued as a follow up to the last FDA inspection of the Company's manufacturing facility in Detroit, Michigan which was initiated in May 2008. As previously disclosed, a Form 483 notice was issued in June 2008 following this inspection.

The details can be read here.

Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer

November 3, 2008 -- Genentech, Inc. today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

The details can be read here.

Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Cephalon, Inc., (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA(R) (bendamustine hydrochloride) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

The details can be read here.

UCB (BE) - Fesoterodine approved in the U.S.

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The details can be read here.

Daiichi Sankyo Acquires Merck Serono's Cardio-Metabolism Sales Force and Products in Turkey

DAIICHI SANKYO ILAÇ TICARET Ltd. Sti., the Turkish subsidiary of Japan's second-largest pharmaceutical company, has obtained 20 members of the cardio-metabolism sales force at Merck ILAÇ Ltd, a subsidiary of Merck Serono in Turkey. The agreement also includes the transfer of marketing-authorization for Concor, an anti-hypertensive medication, and Glucophage, a diabetes agent.

The details can be read here.

Mologen AG receives patent for cell based gene therapy

November 3, 2008 - The Berlin biotech company MOLOGEN AG announced today that the Russian patent office is going to issue the patent for cell based gene therapy against cancer.

The details can be read here.

Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo in the United States

Nov. 3, 2008-Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Wockhardt Limited (Wockhardt) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States.

The details can be read here.

Barr Announces Approval of Generic Camptosar Injection, 20 mg/mL

Barr Pharmaceuticals, Inc. today announced that its subsidiary, PLIVA - Lachema a.s., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pfizer Inc.'s Camptosar(R) (irinotecan hydrochloride) Injection, 20 mg/mL, packaged in 40 mg/2 mL and 100 mg/5 mL vials. The Company plans to launch its product in the fourth quarter of 2008. Barr's U.S. generic injectable portfolio now totals nine products.

The details can be read here.