BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel

Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
Date of Approval: February 14, 2012
Treatment for: Hypogonadism -- Male

Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.

FDA Approves Korlym for Patients with Endogenous Cushing's Syndrome

Company: Corcept Therapeutics
Date of Approval: February 17, 2012
Treatment for: Cushing's Syndrome

Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance.

Novel Drug for Chronic Management of Hyperuricemia in Gout Patients

Teijin Pharma Limited announced the European launch of TMX-67 (febuxostat), a novel drug discovered by for the treatment of hyperuricemia in patients with gout.

Ipsen, a global biotechnology specialty care group and the TMX-67 licensee in Europe, and its sublicensee the Menarini Group, the first Italian pharmaceutical group in the world, have began marketing the product in Europe under the brand name ADENURIC(r).

Orphan Drug Designation for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS)

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced that Soliris(R) (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS).

AHUS is an ultra-rare, inherited, and life-threatening complement-inhibitor deficiency disease that often progresses to end-stage kidney disease or failure. The U.S. Food and Drug Administration granted orphan drug designation to Soliris for the same indication in May 2009.

FDA Grants IBsolvMIR Orphan Drug designation in the treatment of diabetes patients in the U.S.

TikoMed AB, a biotechnology company focused on treatments for immune diseases and cell therapies, announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA).

IBsolvMIR is a unique new treatment which could transform islet cell transplantation into a standard treatment for severe type 1 diabetes patients with unstable diabetic conditions. TikoMed's product IBsolvMIR improves the survival of transplanted cells by inhibiting a destructive immunological reaction and through stimulation of growth factors.

Merck's once-daily, preservative-free ophthalmic medication, Zioptan gets US FDA approval

The US Food and Drug Administration (FDA) has approved Merck’s, Zioptan (tafluprost ophthalmic solution) 0.0015 per cent, the first preservative-free prostaglandin analog ophthalmic solution.

Zioptan (pronounced zye-OP-tan) is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension. Open-angle glaucoma is the most common form of glaucoma, while ocular hypertension is a condition characterized by an increase in pressure inside the eye.

USPTO grants patent for ARIAD Pharma's ponatinib

The United States Patent and Trademark Office (USPTO) has granted US Patent No. 8,114,874  to ARIAD Pharmaceuticals Inc., entitled, “Substituted Acetylenic Imidazo[1,2-B] Pyridazine Compounds as Kinase Inhibitors,” which provides composition-of-matter patent protection through at least December 22, 2026 for ARIAD’s investigational pan-BCR-ABL inhibitor, ponatinib.

Sanofi Wins US Approval for Anti-Lice Shampoo

Drugmaker Sanofi said that it received U.S. approval for a prescription-strength shampoo to treat head lice in children six months old and up.

 

The company's anti-lice Lotion uses a parasite-killing drug called ivermectin, which has long been used in pill-form to treat various worm infestations. Sanofi said in a statement that antilice was developed to "meet the demand for an effective, convenient head lice treatment that works differently and is well-tolerated in children."

FDA OKs Drug for Cancer Patients with Weakened Bones

The FDA has approved the osteoporosis drug Prolia as a treatment for some breast and prostate cancer patients whose bones have been weakened by certain hormone therapies for cancer.

FDA Approved Drugs July 2011

FDA has approved new trade name - Caprelsa - for AstraZeneca's orphan drug vandetanib

The US Food and Drug Administration (FDA) has approved new trade name - Caprelsa - for AstraZeneca's orphan drug vandetanib.

Caprelsa is indicated as a treatment of symptomatic or progressive medullary thyroid cancer in patients suffering from unresectable (non-operable) locally advanced or metastatic disease.

The FDA approval for Caprelsa was given on the basis of results of ZETA Phase III trial which demonstrated improvement in progression-free survival (PFS) when compared to those randomized to placebo.

USFDA: New Drug Application (NDA) & Abbreviated New Drug Application ANDA Approvals September 2011

USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011

USFDA: Abbreviated New Drug Application (ANDA) Approvals November 2011

USDFDA: Abbreviated New Drug Application (ANDA) Approvals December 2011

Novartis receives FDA approval for Arcapta(TM) Neohaler(TM)

Novartis announced that the US Food and Drug Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[1]. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma. 

Novartis drug Glivec receives US FDA approval for expanded use in patients with rare gastrointestinal cancer

The US Food and Drug Administration (FDA) has approved an update to the Glivec (imatinib) label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial. This treatment regimen has been shown to improve recurrence-free survival (RFS) and overall survival (OS) for KIT+ GIST patients compared to 12 months of treatment.

Lupin Receives Final Approval to Market Generic Ultram® ER from US FDA

Lupin Pharmaceuticals, Inc. (LPI) announced on 29^th aug, 2011 that it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ER shortly.

Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation. It is the generic equivalent to Ortho-McNeil’s Ultram®* ER Tablets and is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Tramadol HCl ER tablets had annual sales of approximately $132 million for the twelve months ended June 2011 based on IMS Health sales data.

Source: Lupin Pharma