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Published June 18, 2007
Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sl… Read More »
Published June 18, 2007
Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sl… Read More »
Published June 14, 2007
The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue t… Read More »
Published June 14, 2007
The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue t… Read More »
Published May 31, 2007
Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in th… Read More »
Published May 31, 2007
Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in th… Read More »
Published May 23, 2007
Draxis Pharma, the CMO division of Draxis Health Inc., recently received word from the FDA that its Montreal facilities passed inspection. FDA conducted inspections of all six production and quality systems at Draxis Pharma in January 2007. The inspe… Read More »
Published May 18, 2007
AstraZeneca received approval from the FDA for Seroquel XR Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The Seroquel XR development program was based on the need for a wider choice of medicines… Read More »
Published May 18, 2007
AstraZeneca received approval from the FDA for Seroquel XR Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The Seroquel XR development program was based on the need for a wider choice of medicines… Read More »
Published April 30, 2007
The FDA voted not to approve Merck's NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along… Read More »
Published April 30, 2007
The FDA voted not to approve Merck's NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along… Read More »
Published April 18, 2007
The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achiev… Read More »
Published April 18, 2007
The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achiev… Read More »
Published April 13, 2007
The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck's Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the N… Read More »
Published April 13, 2007
The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck's Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the N… Read More »
Published March 14, 2007
GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycl… Read More »
Published March 14, 2007
GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycl… Read More »
Published March 2, 2007
Astellas Pharma U.S., Inc. received approval from the FDA for Vaprisol, a receptor antagonist for the treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol, discovered and developed by Astellas, is the first drug specifically ind… Read More »
Published March 2, 2007
Astellas Pharma U.S., Inc. received approval from the FDA for Vaprisol, a receptor antagonist for the treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol, discovered and developed by Astellas, is the first drug specifically ind… Read More »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »
Published January 17, 2007
Shire received approval from the FDA for Lialda (mesalamine) with MMX technology, indicated for patients with active mild-to-moderate ulcerative colitis. Lialda is the only FDA-approved once-daily oral formulation of mesalamine. Shire will launch the… Read More »
Published January 17, 2007
Shire received approval from the FDA for Lialda (mesalamine) with MMX technology, indicated for patients with active mild-to-moderate ulcerative colitis. Lialda is the only FDA-approved once-daily oral formulation of mesalamine. Shire will launch the… Read More »
Published January 2, 2007
Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same the… Read More »
Published January 2, 2007
Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same the… Read More »
Published November 17, 2006
Genentech received approval from the FDA for Herceptin, a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with ear… Read More »
Published November 17, 2006
Genentech received approval from the FDA for Herceptin, a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with ear… Read More »
Published October 18, 2006
Merck received approval from the FDA for Januvia for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either metformin or thiazolidinediones (TZDs), to improve blood sugar control in patients with ty… Read More »
Published October 18, 2006
Merck received approval from the FDA for Januvia for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either metformin or thiazolidinediones (TZDs), to improve blood sugar control in patients with ty… Read More »
Published October 16, 2006
Eisai and Pfizer received FDA approval for an sNDA for Aricept for the treatment of severe Alzheimer's disease (AD). With this approval, Aricept becomes the only prescription medication to treat mild, moderate and severe AD. Aricept, which is co-prom… Read More »
Published October 16, 2006
Eisai and Pfizer received FDA approval for an sNDA for Aricept for the treatment of severe Alzheimer's disease (AD). With this approval, Aricept becomes the only prescription medication to treat mild, moderate and severe AD. Aricept, which is co-prom… Read More »
Published October 11, 2006
The FDA has approved Merck's Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Zolinza is man… Read More »
Published October 11, 2006
The FDA has approved Merck's Zolinza capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. Zolinza is man… Read More »
Published October 10, 2006
Quebec-based Confab Laboratories has successfully undergone its second FDA audit for the manufacture and supply of pharmaceutical products to the U.S. The audit was a preapproval inspection for three drug products and demonstrated the company's confo… Read More »
Published September 7, 2006
Cardinal Health, Inc. and Ovation Pharmaceuticals, Inc. received an approval letter from the FDA for Cardinal Health’s new sterile facility in North Raleigh, NC to manufacture Panhemati, an Ovation biologic therapy used to treat acute porphyria… Read More »
Published August 11, 2006
Gene Logic, Inc. entered into an agreement with the FDA to provide the FDA with access to certain genomics data and software, including: a collection of toxicogenomics and rat classical toxicology data from the ToxExpress System including time and do… Read More »
Published July 13, 2006
Bristol-Myers Squibb and Gilead Sciences received approval from the FDA for Atripla for the treatment of HIV-1 infection in adults. Atripla is the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combi… Read More »
Published July 13, 2006
Bristol-Myers Squibb and Gilead Sciences received approval from the FDA for Atripla for the treatment of HIV-1 infection in adults. Atripla is the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combi… Read More »
Published July 11, 2006
Merck received approval from the FDA for Emend for the prevention of postoperative nausea and vomiting (PONV), one of the most common side effects associated with surgical procedures. The recommended dose of Emend for PONV is a single, oral 40 mg dos… Read More »
Published July 11, 2006
Merck received approval from the FDA for Emend for the prevention of postoperative nausea and vomiting (PONV), one of the most common side effects associated with surgical procedures. The recommended dose of Emend for PONV is a single, oral 40 mg dos… Read More »
Published July 6, 2006
The Association of Clinical Research Organizations (ACRO) and the FDA have announced a new initiative to modernize the clinical trial process with the formation of a collaborative group to support the development of data collection standards for regu… Read More »
Published June 9, 2006
Merck/Schering-Plough Pharmaceuticals received FDA approval for Zetia for use, along with diet, in combination with fenofibrate for the reduction of elevated total cholesterol and LDL "bad" cholesterol in patients with mixed hyperlipidemia,… Read More »
Published June 9, 2006
Merck/Schering-Plough Pharmaceuticals received FDA approval for Zetia for use, along with diet, in combination with fenofibrate for the reduction of elevated total cholesterol and LDL "bad" cholesterol in patients with mixed hyperlipidemia,… Read More »
Published June 7, 2006
Pharsight Corp., a provider of software and services for clinical drug development, has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER). Under the terms of the CRA… Read More »
Published May 19, 2006
An FDA advisory committee voted 13 to 0 to endorse Merck vaccine, Gardasil, which blocks a sexually transmitted virus that causes cervical cancer. U.S. advisers unanimously said it was safe and effective for women and girls as young as 9 years old. T… Read More »
Published May 19, 2006
An FDA advisory committee voted 13 to 0 to endorse Merck vaccine, Gardasil, which blocks a sexually transmitted virus that causes cervical cancer. U.S. advisers unanimously said it was safe and effective for women and girls as young as 9 years old. T… Read More »
Published April 7, 2006
Noven Pharmaceuticals has received approval from the FDA for Daytrana as a new therapeutic option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years. Shire, the global licensee of Daytrana, is ex… Read More »
Published April 7, 2006
Noven Pharmaceuticals has received approval from the FDA for Daytrana as a new therapeutic option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years. Shire, the global licensee of Daytrana, is ex… Read More »
Published March 27, 2006
Amgen has received approval from the FDA for extended, every-three-week, dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by th… Read More »
Published March 27, 2006
Amgen has received approval from the FDA for extended, every-three-week, dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by th… Read More »
Published March 2, 2006
ImClone Systems and Bristol-Myers Squibb received approval from the FDA for Erbitux for use in the treatment of squamous cell carcinoma of the head and neck. Designed to inhibit the function of the epidermal growth factor receptor (EGFR)—a mole… Read More »


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