Teva got tentative approval for Lansoprazole: Teva Pharma announced today that the USFDA has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid(R) (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg. The brand product had annual sales of approximately $3.4 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of Delaware involving Teva's paragraph IV certification to U.S. Patent Nos. 4,628,098 and 5,045,321. A trial was held in November, at the end of which the Court indicated it anticipates it will issue a decision before the June 7, 2008 expiration of the mandatory 30-month stay of FDA approval associated with the patent litigation.
Teva filed Para IV on Fenofibrate: Fournier Lab Ireland Ltd, a wholly-owned unit of Solvay Pharmaceuticals, was informed by Teva Pharmaceuticals that it has filed an ANDA - Abbreviated New Drug Application - with a Paragraph IV certification, seeking the approval of a generic version of TriCor® (Fenofibrate) 145mg NFE tablets in the United States.The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.Such procedures are not unusual for branded products in the United States. Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.
Banner Pharm got approval for Nimodipin: Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the USFDA has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Nimodipine 30 mg soft gelatin capsules. Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop(R) 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles. Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.
USFDA approved Micafungin sodium sNDA: Astellas Pharma Inc. announced today that the USFDA has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE® (Micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. MYCAMINE was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
NovaDel Pharma filed NDA for zolpidem tartrate Oral Spray: NovaDel Pharma Inc., a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced today that the USFDA has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines. NovaDel submitted its ZolpiMist(TM) application using the FDA's 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R). Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
USFDA has approved Colesevelam HCl: Daiichi Sankyo, Inc, said the USFDA has approved its cholesterol drug Welchol (Colesevelam HCl) to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C) in adults with type 2 diabetes.
Teva filed Para IV on Fenofibrate: Fournier Lab Ireland Ltd, a wholly-owned unit of Solvay Pharmaceuticals, was informed by Teva Pharmaceuticals that it has filed an ANDA - Abbreviated New Drug Application - with a Paragraph IV certification, seeking the approval of a generic version of TriCor® (Fenofibrate) 145mg NFE tablets in the United States.The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.Such procedures are not unusual for branded products in the United States. Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.
Banner Pharm got approval for Nimodipin: Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the USFDA has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Nimodipine 30 mg soft gelatin capsules. Banner's Nimodipine 30 mg capsules are the AB-rated generic equivalent of Bayer's Nimotop(R) 30 mg capsules, and are indicated for the treatment of subarachnoid hemorrhage, a form of cerebral bleed. Banner's product can be dispensed either in blister packaging or in bottles. Banner has partnered with Heritage Pharmaceuticals Inc., an Edison, New Jersey based generics company, for the exclusive US sales and marketing rights for Nimodipine.
USFDA approved Micafungin sodium sNDA: Astellas Pharma Inc. announced today that the USFDA has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE® (Micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. MYCAMINE was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
NovaDel Pharma filed NDA for zolpidem tartrate Oral Spray: NovaDel Pharma Inc., a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced today that the USFDA has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines. NovaDel submitted its ZolpiMist(TM) application using the FDA's 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R). Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
USFDA has approved Colesevelam HCl: Daiichi Sankyo, Inc, said the USFDA has approved its cholesterol drug Welchol (Colesevelam HCl) to reduce both glucose levels and low density lipoprotein cholesterol levels (LDL-C) in adults with type 2 diabetes.
