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Published March 24, 2010
Belgian site to produce lyophilized cytotoxic cancer treatment Read More »
Published March 5, 2010
Gary Buehler, the director of the FDA’s Office of Generic Drugs, has changed positions at the agency and will now serve in the Office of Pharmaceutical Science, which oversees the generics area. Read More »
Published February 17, 2010
Haupt site cleared to produce sterile penicillins for U.S. market Read More »
Published January 25, 2010
Sinobiopharma’s production facility for solid dosage Perindopril has passed Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing. Read More »
By Gary C. Messplay and Colleen Heisey
Published January 22, 2010
A busy year for the agency Read More »
Published January 22, 2010
Genzyme’s BLA for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale, has received a June 17, 2010 PDUFA date from the FDA. Read More »
Published January 22, 2010
Genzyme’s BLA for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale, has received a June 17, 2010 PDUFA date from the FDA. Read More »
Published January 18, 2010
The FDA has extended the review period for OSI Pharmaceuticals and Genentech’s sNDA for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. Read More »
Published January 18, 2010
The FDA has extended the review period for OSI Pharmaceuticals and Genentech’s sNDA for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. Read More »
Published January 4, 2010
The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine. Read More »
Published January 4, 2010
The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine. Read More »
Published November 30, 2009
The FDA sent a "refuse to file" letter to EMD Serono for the NDA for Cladribine Tablets Read More »
Published November 30, 2009
The FDA sent a "refuse to file" letter to EMD Serono for the NDA for Cladribine Tablets Read More »
Published October 19, 2009
Amgen received a Complete Response Letter from the FDA for Prolia's BLA Read More »
Published October 19, 2009
Amgen received a Complete Response Letter from the FDA for Prolia's BLA Read More »
Published August 28, 2009
Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Read More »
Published August 28, 2009
Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Read More »
Published August 19, 2009
Catalent's softgel facility in Buenos Aires successfully completed its first FDA cGMP audit and PAI Read More »
Published August 19, 2009
CSL Biotherapies, a subsidiary of CSL Limited, received licensure from the FDA for its newest vaccine filling and packaging facility in Kankakee, IL. Read More »
Published August 12, 2009
The FDA has extended the action date by 90 days for its review of Prevnar 13 Read More »
Published August 12, 2009
The FDA has extended the action date by 90 days for its review of Prevnar 13 Read More »
Published August 3, 2009
Bristol-Myers Squibb and AstraZeneca received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Read More »
Published August 3, 2009
Bristol-Myers Squibb and AstraZeneca received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Read More »
Published July 31, 2009
The FDA will re-inspect Genzyme’s Allston Landing manufacturing facility. Read More »
Published July 13, 2009
The FDA has approved the NDA by Daiichi Sankyo and Eli Lilly and Co. for Effient (prasugrel) tablets Read More »
Published July 13, 2009
The FDA has approved the NDA by Daiichi Sankyo and Eli Lilly and Co. for Effient (prasugrel) tablets Read More »
Published July 2, 2009
The FDA has approved Sanofi-Aventis's Multaq (dronedarone) 400 mg tablets for patients with atrial fibrillation (AF) or atrial flutter (AFL). Read More »
Published July 2, 2009
The FDA has approved Sanofi-Aventis's Multaq (dronedarone) 400 mg tablets for patients with atrial fibrillation (AF) or atrial flutter (AFL). Read More »
Published June 18, 2009
Novartis received approval from the FDA for Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating sympt Read More »
Published June 18, 2009
Novartis received approval from the FDA for Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating sympt Read More »
Published May 11, 2009
Eurand received approval from the FDA for EUR-1048, to be marketed as GlaxoSmithKline's Lamictal ODT (lamotrigine) Orally Disintegrating Tablets. Read More »
Published May 11, 2009
Eurand received approval from the FDA for EUR-1048, to be marketed as GlaxoSmithKline's Lamictal ODT (lamotrigine) Orally Disintegrating Tablets. Read More »
Published March 31, 2009
WuXi AppTec's Bioanalytical Services (BAS) unit was successfully inspected by the FDA without the issuance of a Form 483.WuXi AppTec's Bioanalytical Services (BAS) unit was successfully inspected by the FDA without the issuance of a Form 483. Read More »
Published February 27, 2009
Genzyme received approval from the FDA for Synvisc-One (hylan G-F 20), for the relief of pain associated with osteoarthritis (OA) of the knee. Read More »
Published February 27, 2009
Genzyme received approval from the FDA for Synvisc-One (hylan G-F 20), for the relief of pain associated with osteoarthritis (OA) of the knee. Read More »
Published February 9, 2009
GTC Biotherapeutics and Ovation Pharmaceuticals, Inc. received approval from the FDA for ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Read More »
Published February 9, 2009
GTC Biotherapeutics and Ovation Pharmaceuticals, Inc. received approval from the FDA for ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. Read More »
By Gary C. Messplay and Colleen Heisey
Published January 22, 2009
New document covers principles and practices guiding process validation Read More »
Published January 19, 2009
Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal wome… Read More »
Published January 19, 2009
Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal wome… Read More »
Published January 14, 2009
The FDA completed an inspection of Apicore LLC's kilo-scale API manufacturing site in Somerset, NJ. The inspection took place December 12-15, 2008, according to Compliance Program 7356.002F, “Drug Manufacturing Inspections for Bulk Pharmaceutic… Read More »
Published December 15, 2008
The FDA has granted Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterf… Read More »
Published December 15, 2008
The FDA has granted Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterf… Read More »
Published November 17, 2008
The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval… Read More »
Published November 17, 2008
The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval… Read More »
Published November 3, 2008
Cephalon, Inc., received approval from the FDA for Treanda 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-contai… Read More »
Published November 3, 2008
Cephalon, Inc., received approval from the FDA for Treanda 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-contai… Read More »
Published October 17, 2008
Catalent Pharma Solutions received notice that the FDA has approved the sale of a prescription product manufactured at its recently opened pre-filled syringe facility in Brussels, Belgium. Syringes from the Brussels facility will likely be dispensed… Read More »
Published October 10, 2008
Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.     The agency indicated that du… Read More »
Published October 10, 2008
Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.     The agency indicated that du… Read More »


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