Medical Product Guide» Cancer

Roxane Receives FDA Approval For Anastrozole Tablets

Jim Marino — Fri, 09 Jul 2010 19:14:49 +0000

Roxane Laboratories has received approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the FDA. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies across the US. Roxane Laboratories’ Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.

TetraLogic Pharmaceuticals Initiates Phase 1 Clinical Trial Of TL32711 In Patients With Refractory Solid Tumors Or Lymphoma

Jim Marino — Mon, 18 Jan 2010 15:30:57 +0000

TetraLogic Pharmaceuticals announced that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

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Switching To Letrozole Helps Breast Cancer Patients With Anastrozole-Related Rheumatologic Symptoms

Jim Marino — Mon, 04 Jan 2010 11:56:17 +0000

Postmenopausal women with hormone receptor-positive (HR+) breast cancer who develop arthralgia and/or myalgia (A/M) while being treated with anastrozole may want to consider a switch to letrozole therapy, researchers said at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Women who experienced greater than equal to grade 2 A/M while receiving anastrozole and switched to letrozole developed significantly less A/M and had an improved quality of life compared with baseline.

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FDA approves painkiller Onsolis

admin — Mon, 20 Jul 2009 08:10:18 +0000

BioDelivery Sciences International Inc has received approval from the FDA to market Onsolis to treat breakthrough pain in certain cancer patients. The drug is expected to be available in the fourth quarter of 2009 and will be commercialized in the US by Meda Pharmaceuticals. Onsolis delivers the potent opioid fentanyl via a film that sticks to the inside of a patient’s cheek.

FDA approves generic Camptosar in chemotherapy

Jim Marino — Tue, 11 Mar 2008 14:27:21 +0000

Teva Pharmaceutical Industries has received FDA approval for the Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection. Camptosar’s patent expired last month and the drug had annual sales of about $556 million in the U.S. in the twelve months ended December 31, 2007. The other companies that have received approval to launch the generic version of Pfizer’s chemotherapy agent are Actavis and APP Pharmaceuticals.

Orchid receives FDA nod for generic Kytril

Jim Marino — Mon, 25 Feb 2008 15:11:50 +0000

Orchid Chemicals & Pharmaceuticals Ltd. has received FDA approval for its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride tablets in the 1-mg strength. Granisetron Hydrochloride tablets are a generic form of Roche’s Kytril drug, used to treat nausea induced by chemotherapy and radiation therapies. Orchid is the first Indian company to get an FDA approval for a non-antibiotic product.

Rituxan reduces relapses in MS

Jim Marino — Fri, 22 Feb 2008 15:18:15 +0000

Rituxan (rituximab), the blockbuster cancer drug sold by Genentech Inc. and Biogen-Idec, reduced brain lesions and their relapse in multiple sclerosis patients, according to a study published in the New England Journal of Medicine. The UCSF researchers, led by Stephen Hauser, observed 104 patients for a 48-week period. The study showed that only 20% of the patients who received Rituxan suffered from a relapse, as compared to 40% of those who received placebo.

APP receives FDA nod for its two generics

Jim Marino — Mon, 11 Feb 2008 17:41:31 +0000

APP Pharmaceuticals Inc. has received FDA approval for two generic dugs. The regulatory agency has approved APP Pharma’s Abbreviated New Drug Application (ANDA) for Caffeine Citrate Oral Solution, 20 mg/ml, which is a generic version of Bedford Laboratories’ Cafcit Oral Solution used for the short-term treatment of apnea in premature infants. The FDA has also approved the ANDA for bleomycin sulfate for injections, the generic version of Bristol-Myers Squibb’s cancer treatment drug Blenoxane.