LYON, France I June 30, 2014 I Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for VAZCULEP™ (phenylephrine hydrochloride). VAZCULEP Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel expects to launch VAZCULEP in the next few months in 1 mL single use vials, and 5 mL and 10 mL pharmacy bulk package vials. The drug strength is the same in all vials at 10 mg/mL. Phenylephrine hydrochloride is used in operating rooms and is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.
“We are extremely pleased to receive NDA approval for VAZCULEP from the FDA,” said Mike Anderson, Chief Executive Officer of Flamel. “This is the second product from the portfolio of UMDs (Unapproved Marketed Drugs) products following the FDA approval of Bloxiverz™ in May 2013. Both of these drugs are used by anesthesiologists in hospital settings.”
VAZCULEP is the only FDA-approved version of phenylephrine hydrochloride to be available in all three vial sizes, which will be of great convenience to hospitals and physicians. One other company has an FDA-approved version of the 1 mL single use vials. Based on our knowledge, there is another company that offers unapproved versions of phenylephrine hydrochloride, but only in the 5 mL and 10 mL pharmacy bulk package vials. These unapproved versions have been on the market as grandfathered products under the Food, Drug and Cosmetic Act of 1938.
“Based on our marketing experience, we believe that hospitals will welcome the addition of VAZCULEP as an FDA-approved version of phenylephrine hydrochloride in all vial sizes,” continued Mr. Anderson.
Safety Information
Adverse reactions to VAZCULEP are primarily attributable to excessive pharmacologic activity. These adverse reactions can be categorized as follows:
Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias
Gastrointestinal disorders: Epigastric pain, vomiting, nausea
Nervous system disorders: Headache, blurred vision, neck pain, tremors
Vascular disorders: Hypertensive crisis
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea
Skin and subcutaneous tissue disorders: Pruritis
About VAZCULEP (Phenylephrine Hydrochloride)
Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist. Interaction of phenylephrine with α1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following phenylephrine hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid, typically within minutes. As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia. Phenylephrine has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.
About Flamel Technologies. Flamel Technologies SA’s (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The company markets Bloxiverz™ (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles under FDA-audited GMP guidelines for Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes biological and chemical drugs formulated with its Medusa™ and Micropump® (and its applications to the development of liquid formulations, i.e. LiquiTime® and of abuse-deterrent formulations Trigger Lock™) proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at www.flamel.com.
SOURCE: Flamel Technologies
Post Views: 112
LYON, France I June 30, 2014 I Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for VAZCULEP™ (phenylephrine hydrochloride). VAZCULEP Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel expects to launch VAZCULEP in the next few months in 1 mL single use vials, and 5 mL and 10 mL pharmacy bulk package vials. The drug strength is the same in all vials at 10 mg/mL. Phenylephrine hydrochloride is used in operating rooms and is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.
“We are extremely pleased to receive NDA approval for VAZCULEP from the FDA,” said Mike Anderson, Chief Executive Officer of Flamel. “This is the second product from the portfolio of UMDs (Unapproved Marketed Drugs) products following the FDA approval of Bloxiverz™ in May 2013. Both of these drugs are used by anesthesiologists in hospital settings.”
VAZCULEP is the only FDA-approved version of phenylephrine hydrochloride to be available in all three vial sizes, which will be of great convenience to hospitals and physicians. One other company has an FDA-approved version of the 1 mL single use vials. Based on our knowledge, there is another company that offers unapproved versions of phenylephrine hydrochloride, but only in the 5 mL and 10 mL pharmacy bulk package vials. These unapproved versions have been on the market as grandfathered products under the Food, Drug and Cosmetic Act of 1938.
“Based on our marketing experience, we believe that hospitals will welcome the addition of VAZCULEP as an FDA-approved version of phenylephrine hydrochloride in all vial sizes,” continued Mr. Anderson.
Safety Information
Adverse reactions to VAZCULEP are primarily attributable to excessive pharmacologic activity. These adverse reactions can be categorized as follows:
Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias
Gastrointestinal disorders: Epigastric pain, vomiting, nausea
Nervous system disorders: Headache, blurred vision, neck pain, tremors
Vascular disorders: Hypertensive crisis
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea
Skin and subcutaneous tissue disorders: Pruritis
About VAZCULEP (Phenylephrine Hydrochloride)
Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist. Interaction of phenylephrine with α1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following phenylephrine hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid, typically within minutes. As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia. Phenylephrine has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.
About Flamel Technologies. Flamel Technologies SA’s (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The company markets Bloxiverz™ (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles under FDA-audited GMP guidelines for Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes biological and chemical drugs formulated with its Medusa™ and Micropump® (and its applications to the development of liquid formulations, i.e. LiquiTime® and of abuse-deterrent formulations Trigger Lock™) proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at www.flamel.com.
SOURCE: Flamel Technologies
Post Views: 112
