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"FUTURE GP DRUGS ON THE HORIZON"
June 23, 2008-Tranzyme Pharma Announces Successful
Thorough QT/QTc Study of Ghrelin Agonist TZP-101
Tranzyme Pharma announces the successful results from a “Thorough QT/QTc” study of the company’s
lead product TZP-101, an intravenous gastrointestinal prokinetic agent currently in two Phase IIb trials for the treatment
of postoperative ileus (POI) and severe gastroparesis.
The study, required by the US Food and Drug Administration (FDA) for all new chemical entities,
was conducted to evaluate the cardiac safety of TZP-101, with a focus on cardiac repolarization as measured by the duration
of the QT interval in serial electrocardiograms (ECG). TZP-101 has a novel mechanism acting
as an agonist of the body’s ghrelin receptors, whereas other known gastrointestinal (GI) prokinetics act on serotonin
receptors and have been linked to life-threatening cardiac side effects related to QT interval prolongation resulting in their
restriction or removal from the market.
The trial was a double-blind, randomized, parallel study which compared
the ECG effects of TZP-101, given at a therapeutic (160μg/kg daily for 5 days) and a supratherapeutic dose (600μg/kg daily for 5 days), to placebo and moxifloxacin (a positive control
known to increase the QT interval) in 160 healthy men and women. The primary analysis was centered on a time-matched change
from baseline in corrected QT interval (QTc) based on an individual correction method.
“The extensive data, including a careful pharmacokinetic-pharmacodynamic analysis, from this
validated trial, clearly show that TZP-101 does not affect cardiac repolarization,” stated Gordana Kosutic, MD, Tranzyme’s
VP, Clinical and Regulatory Affairs. “The results further demonstrate that TZP-101 has no effect on heart rate, PR and
QRS interval duration or cardiac morphology, and thus continues to substantiate the compound’s pronounced cardiovascular
safety profile,” she added.
About TZP-101
TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb
trials for the treatment of postoperative ileus (POI) and severe gastroparesis. The safety and pharmacokinetic profile of
TZP-101 has been extensively characterized in healthy subjects across multiple dose levels, and the prokinetic properties
of the compound have been well established in various animal models and a preliminary investigation in diabetic patients.
In addition to TZP-101, Tranzyme is developing an oral ghrelin agonist, TZP-102, currently in Phase I trials for the treatment
of mild-to-moderate gastroparesis and other chronic GI motility disorders.
About Postoperative Ileus
Postoperative ileus is a transient impairment of GI motility following abdominal or other surgery.
Common symptoms include abdominal distention or bloating, pain, nausea and vomiting, and inability to pass stools and tolerate
a solid diet. A delay in resuming a normal diet may lead to poor healing through a cascade of events. A greater risk for pulmonary
complications also exists, since POI may result in reduced patient mobility. POI is associated with an increased length of
hospital stay and is the most common cause of delayed hospital discharge after abdominal surgery. In the United States alone,
it is estimated that 22 million patients undergo surgical procedures requiring pain management and of these patients, 2.4
million undergo high risk open surgery each year (Source: Premier Database). No unrestricted treatments for POI have been
approved by the US Food and Drug Administration to date.
June 17, 2008-Tranzyme Pharma’s Ghrelin Agonist TZP-102 Demonstrates Safety
and High Oral Bioavailability in the Successful Completion of a Phase I Trial
RESEARCH TRIANGLE PARK, N.C. (June 17, 2008) - Tranzyme Pharma announced
today the successful completion of a Phase I, placebo-controlled, single ascending dose study of its orally-administered ghrelin
agonist, TZP-102. TZP-102 is the second drug candidate from Tranzyme’s internal R&D efforts to reach clinical development.
It is a potent prokinetic agent initially being developed for the treatment of mild-to-moderate gastroparesis.
The
Phase I study showed that TZP-102 has excellent oral bioavailability in man and is safe and well-tolerated at all five doses
(10-80 mg) tested. Most importantly, all doses achieved plasma concentrations of TZP-102 above those associated with
significantly increased rates of gastric emptying in a validated animal model. A multi-dose Phase I study of TZP-102 in healthy
volunteers has been initiated and the company expects to begin its first proof-of-concept trial of TZP-102 in the fourth quarter
of 2008.
TZP-102
is a product that complements Tranzyme’s pipeline of first-in-class therapeutics for the treatment of both acute (hospital
based) and chronic gastrointestinal and metabolic disorders with significant unmet medical needs. Whereas TZP-102 is expected
to be developed for the management of chronic gastrointestinal disorders, Tranzyme’s lead drug candidate, TZP-101, is
an injectable ghrelin agonist being evaluated in two concurrent Phase IIb trials for the treatment of acute indications, severe
gastroparesis and post-operative ileus (POI).
“Tranzyme’s
novel approach to drug discovery allows our compounds to retain the favorable characteristics of small molecules, such as
the high oral bioavailability demonstrated by TZP-102, while exhibiting the characteristics of large biomolecules, such as
tight receptor binding for high potency and exquisite target selectivity,” stated Helmut Thomas, Ph.D., DABT, Sr. Vice
President, Research and Preclinical Development of Tranzyme Pharma.
About TZP-102
TZP-102
is a first-in-class, orally administered GI prokinetic agent that acts by a mechanism distinct from previously developed products
for gastrointestinal (GI) motility disorders. TZP-102 is an agonist of ghrelin receptors found in both the upper and lower
GI tract. The drug is expected to enter Phase II development in late 2008.
June 5, 2008-Tranzyme Pharma to Present “Ghrelin
Agonist (TZP-101) Effects on Patients with Severe Symptomatic Diabetic Gastroparesis” at ADA 2008
RESEARCH TRIANGLE PARK, N.C. (June 5, 2008) - Tranzyme Pharma, a leading biopharmaceutical company that discovers and develops small molecule drugs
for the treatment of gastrointestinal and metabolic diseases, announced today that Dr. Niels Ejskjaer, MD, PhD of Aarhus University
Hospital, Denmark, will present Phase IIa trial results of Tranzyme’s first-in-class ghrelin agonist TZP-101 at the
American Diabetes Association, 68th Annual Meeting to be held in
San Francisco, CA, June 6-10, 2008.
Using scintigraphy and a standardized radiolabeled meal, this double blind, randomized, two-way
crossover study assessed the effects of TZP-101 on gastric emptying in 10 patients with long standing type 1 or type 2 diabetes
and severe symptomatic gastroparesis. Data show that TZP-101 induced a statistically significant reduction in half-emptying
time (p=0.043) and latency time (p=0.037) of the solid meal. It is of special significance that gastric emptying of the solid
meal was normalized in 30% of patients after a single TZP-101 infusion. Half-emptying and latency times for liquids were reduced
as well. Further, TZP-101 infusion decreased a cumulative meal-related symptom score in 5 of 8 patients with an overall improvement
of 24%. Postprandial fullness, the most frequent and severe symptom observed in the study, was reduced by 37%.
“No efficient pharmacotherapy exists for diabetic gastroparesis, thus threatening the health
of diabetic patients,” stated Dr. Ejskjaer, the study’s principal investigator. “This TZP-101 proof-of-concept
study data show a clinically relevant improvement of gastric emptying and suggest that TZP-101 is a promising agent for the
management of gastroparesis,” he added.
The abstract number 298-OR will be presented
in Room 130 of the Moscone Center on Monday, June 9, 2008 at 6:15pm.
About TZP-101
TZP-101 is an intravenous ghrelin agonist that Tranzyme is evaluating in two concurrent Phase IIb
trials for the treatment of severe gastroparesis and post-operative ileus (POI). The safety and pharmacokinetic profile of
TZP-101 has been extensively characterized in healthy subjects across multiple dose levels, and the prokinetic properties
of the compound have been well established in various animal models. In addition to TZP-101, Tranzyme is developing an oral
ghrelin agonist, TZP-102, for the treatment of mild-to-moderate gastroparesis and other chronic GI motility disorders.
About Gastroparesis
Gastroparesis is an impairment or paralysis of upper gastrointestinal
tract function characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis
include post-prandial fullness, early satiety, abdominal pain, nausea, vomiting, and weight loss. Disease severity ranges
from mild to severe. Gastroparesis is a major complication of diabetes leading to metabolic imbalance when liquid and food
intake and absorption of oral medications is impaired. Gastroparesis may also result from abdominal surgery or be idiopathic
in nature. Current medications for the treatment of gastroparesis
are only moderately effective and many are associated with adverse neurological side effects. It is estimated that approximately 5 million patients suffer from gastroparesis in the United
States.
RESEARCH TRIANGLE PARK, N.C. (March 3, 2008) - Tranzyme Pharma
today announced that it has commenced dosing in a Phase I study of TZP-102, the Company’s second generation, orally-administered
ghrelin agonist. TZP-102 is a potent prokinetic agent that Tranzyme is initially developing for the treatment of mild-to-moderate
gastroparesis, with other chronic gastrointestinal (GI) motility disorders to follow.
Tranzyme
develops small molecule drugs from its proprietary macrocyclic chemistry platform, MATCHTM, for the treatment of
GI and metabolic diseases. TZP-102 operates through the same mechanism of action as the lead drug, TZP-101, an intravenous
ghrelin agonist currently undergoing Phase IIb trials for the treatment of post-operative ileus (POI) and severe gastroparesis.
“We
are very excited to begin characterizing the safety and tolerability of TZP-102,” said Gordana Kosutic, M.D., Tranzyme’s
Vice President, Regulatory and Clinical Affairs. “We anticipate progressing TZP-102 into Phase II investigation by the
end of this year.”
“Gastrointestinal
disorders are expected to affect over 250 million people worldwide by 2012,” stated Vipin K. Garg, Ph.D., President
& CEO of Tranzyme Pharma. “Having two GI promotility drug candidates in the clinic is a great milestone for Tranzyme,
and is extremely encouraging for patients and caregivers alike since many competing promotility agents have safety issues
that have resulted in their restriction or removal from the market.”
About Gastroparesis
About Tranzyme
Pharma
Tranzyme
Pharma is a clinical stage biopharmaceutical company focused on developing and commercializing breakthrough small molecule
therapeutics for diseases where there is a significant unmet medical need. Tranzyme has developed a pipeline of novel drugs
for the treatment of gastrointestinal and metabolic diseases. For more information, please visit: www.tranzyme.com.
Tranzyme Pharma Receives IND Clearance
for Its Oral Ghrelin Agonist,
TZP-102, for the Treatment of Gastroparesis
Phase I Safety and Tolerability Trial
to Begin
RESEARCH TRIANGLE PARK, N.C. (January 29, 2008) - Tranzyme Pharma
announced today that the US Food
and Drug Administration (FDA)
completed its review of the Company's Investigational New Drug (IND)
application for TZP-102,
Tranzyme's second drug candidate to reach
clinical development.
Tranzyme is a clinical stage company developing
small molecule drugs
for the treatment of gastrointestinal (GI) and metabolic diseases.
TZP-102 operates on the same
mechanism of action as the Company's
lead product TZP-101, an intravenous ghrelin agonist currently
undergoing Phase
IIb trials for the treatment of two distinct acute
GI motility disorders: post-operative ileus (POI) and severe
gastroparesis.
TZP-102 is a second generation prokinetic drug that
Tranzyme intends to develop for the treatment of mild-to-moderate
gastroparesis
and other chronic GI motility disorders. A Phase I
safety and tolerability trial of TZP-102 will begin immediately.
"Advancing
TZP-102 into clinical development further strengthens our
product pipeline," commented Vipin K. Garg, Ph.D., President
& CEO of
Tranzyme Pharma. "Acceptance of this IND by the FDA represents a
significant milestone for Tranzyme as
well as for the technology
underlying the discovery and development of this product. TZP-102 is
the second clinical
candidate to originate from our proprietary
macrocyclic chemistry platform, MATCHTM," Dr. Garg added.
"We are genuinely
excited by the progression of TZP-102 to the clinic
as preclinical evidence suggests this oral prokinetic agent has
therapeutic
potential for symptomatic relief and management of
chronic gastroparesis," stated Gordana Kosutic, M.D., Tranzyme's Vice
President,
Regulatory and Clinical Affairs.
About Gastroparesis
Gastroparesis is a paralysis of upper gastrointestinal
tract function
characterized by delayed gastric emptying in the absence of
mechanical obstruction. Symptoms of gastroparesis
include post-
prandial fullness, early satiety, nausea, vomiting, and upper
abdominal pain. Disease severity ranges
from mild to moderate to
severe. Gastroparesis is a major complication of diabetes; it may
also result from abdominal
surgery and can be idiopathic in nature.
*NO EFFICACIOUS THERAPY IS AVAILABLE
FOR GASTROPARESIS. CURRENT
TREATMENTS ARE ONLY MODERATELY EFFECTIVE AND MANY ARE ASSOCIATED
WITH ADVERSE NEUROLOGICAL
SIDE EFFECTS.
It is estimated that approximately 5 million patients suffer from
Gastroparesis in the United
States.
MOVETIS NV -Belgian Biopharmaceutical Company
Two Movetis Compounds Successfully Progressing Through Phase II Clinical Trials In Gastrointestinal (GI) Disorders-Gastroparesis-Results
from clinical trial in 2009
Turnhout, 08 January 2008, Movetis NV, a European-based specialist pharmaceutical company, announced
today that M0002, an orally-active selective V2 vasopressin antagonist for the treatment of ascites has successfully completed
enrollment in a Phase IIa clinical trial, and that M0003, an innovative gastrokinetic compound for the treatment of paediatric
reflux and gastroparesis has now begun a Phase IIa clinical trial in patients with gastroparesis.
M0003 is a powerful, and specific, high affinity 5-HT4 agonist that stimulates upper GI motility and accelerates
gastric emptying at low dose. It is currently being studied for the treatment of gastroparesis, a disorder in which the stomach
takes too long to empty its contents, as well as paediatric reflux, or involuntary regurgitation of gastric contents into
the oesophagus. Results from the Phase IIa clinical trial of M0003 in gastroparesis are expected in 2009.
'We are encouraged
to see that our compounds are successfully progressing through research on time and within budgets. Obviously we are honoured
that the IWT institute feels our programme merits such a grant and we are committed to work with them to progress innovation
and create jobs in our region." commented Dirk Reyn, CEO of Movetis "Through these grants and the support of our distinguished
investors, we can pursue our path to discover, develop and ultimately commercialise innovative treatments targeting selected
GI conditions where patients do not get adequate relief from older drugs with less favourable benefit/risk profiles" .
*MOVETIS NV - founded 2007 - is an independent Belgian biopharmaceutical company which specializes
in developing compounds for gastrointestinal (GI) disorders. The current portfolio has been licensed from Janssen Pharmaceutica
NV, Belgium and Ortho-McNeil Pharmaceutical Inc., US, two Johnson & Johnson (JNJ) companies.
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"Tranzyme Pharma"
Tranzyme Pharma to Present at the
26th Annual JPMorgan Healthcare Conference
RESEARCH TRIANGLE PARK, N.C. & SHERBROOKE, Quebec--(BUSINESS
WIRE)--Tranzyme
Pharma, a leading biopharmaceutical company developing small molecule drugs for
the treatment of gastrointestinal
(GI) and metabolic diseases, announced today
that Vipin K. Garg, Ph.D., President and CEO, will present at the upcoming
26th
Annual JPMorgan Healthcare Conference being held from January 7-10, 2008.
Tranzyme’s presentation will take
place on Monday, January 7, 2008 at 3:30 p.m.
PST at the Westin St. Francis Hotel in San Francisco, CA.
Dr. Garg
will provide a corporate overview and an update on the two ongoing
Phase IIb clinical trials of Tranzyme’s lead product,
TZP-101, an intravenous
ghrelin agonist being investigated for the treatment of severe gastroparesis and
post-operative
ileus. In July 2007, the FDA granted TZP-101 fast-track
designation for severe gastroparesis.
*FDA PUTS NEW GASTROPARESIS MEDICATION ON FAST TRACK-TREATMENT AVAILABLE ON
THE MARKET-2010
Durham biotech Tranzyme Pharma has received fast-track status from the U.S. Food and Drug Administration for its drug TZP-101
- a move that could have the treatment to market within three years.
That's six months to a year quicker than Tranzyme could have hoped for without
fast-track designation. No wonder, then, that the company's looking to the future - and even to an initial public offering
by 2009.
"We're a smart group of people," says Eric Nelson, the company's vice president
of business development. "We're planning ahead."
The FDA designation, meant to speed the release to market of drugs that address
unmet medical needs, will give Tranzyme expedited review of TZP-101. The drug is a treatment for severe gastroparesis, a condition
in which damaged stomach nerves lead to delays in digestion. Severe gastroparesis can lead to nausea and vomiting, and it
can also interfere with the treatment of diabetes.
Eric Nelson, Tranzyme vice president of business development, said fast-track status
puts the company on pace to bring the drug to market in 2010, with full phase II trials set to start in the third quarter
of 2007.
The company estimates that the worldwide market for the treatment of severe gastroparesis
is $500 million annually.
Tranzyme, which has 10 employees in the Triangle and 40 overall, also is developing
TZP-101 for the treatment of post-operative ileus, a condition in which patients' bowels stop working or work too slowly after
surgery. The worldwide market for that condition is $1 billion, Nelson said.
Also $1 billion: the market for TZP-102, an oral form of TZP-101 for less severe
gastroparesis. That drug is in preclinical trials and could enter human studies later this year.
Those are not small numbers. Nor is the $32 million the company raised in its last
round of financing in May 2005 from lead investors H.I.G. Ventures, Quaker BioVeutures and Thomas, McNerney & Partners.
But for the company to make the money, Nelson said, it first has to raise the money
for its trials.
In the short term, that means following one of three paths: partnering with a major
pharmaceutical company, taking in another round of financing or doing both. Of those, Nelson says, "Frankly, we're evaluating
all those options."
And in the longer term? Perhaps an initial public offering, maybe next year or
in 2009. The company has already attracted interest from multiple investment banks, though Nelson declined to give names.
"Things are looking very good," Nelson said.
Tranzyme
Pharma Closes New $20 Million Financing
RESEARCH
TRIANGLE PARK, N.C. and SHERBROOKE, Québec (November 1, 2007) - Tranzyme Pharma, a leading biopharmaceutical
company developing small molecule drugs for the treatment of gastrointestinal (GI) and metabolic diseases, announced today
that it has completed a new round of private financing, raising a total of $20 million. The financing was led by existing
investors H.I.G. Ventures, Thomas, McNerney & Partners, Quaker BioVentures, and BDC Venture Capital.
Tranzyme intends
to use this funding to further advance clinical development of its breakthrough GI drugs. Tranzyme’s lead products are
first-in-class drugs directed at modulating ghrelin and motilin receptors in the GI tract. The Company recently initiated
two Phase IIb clinical trials to test the efficacy and safety of its first product, TZP-101, an intravenous ghrelin receptor
agonist being investigated for the treatment of severe gastroparesis and post-operative ileus. In July 2007, the FDA granted
TZP-101 fast-track designation for severe gastroparesis.
Tranzyme’s pipeline also includes TZP-102, an oral ghrelin
agonist for the treatment of mild-to-moderate (chronic) gastroparesis and other functional GI disorders. In addition, the
Company is developing a motilin antagonist, TZP-201, for moderate to severe diarrhea, and a ghrelin antagonist, TZP-301 for
obesity and metabolic syndrome.
“Tranzyme has made tremendous progress since the last round of financing in 2005
and all of its investors are extremely excited by the blockbuster potential of the Company’s mechanism-based drug candidates,”
stated David J. Drutz, M.D., Chairman of Tranzyme Pharma’s board, and General Partner with Pacific Rim Ventures, Co.,
Ltd.
“This round of financing reflects the continued support and confidence we are so fortunate to have from
our investors,” stated Vipin K. Garg, Ph.D., President and Chief Executive Officer of Tranzyme. This capital will allow
us to bring our first-in-class GI motility drug, TZP-101, into Phase III clinical studies for multiple indications.”
Tranzyme Pharma Initiates Dosing of
Patients in a Multi-National
Phase IIb Clinical Trial for the Treatment of Severe Gastroparesis
RESEARCH TRIANGLE
PARK, N.C. and SHERBROOKE, Québec (October 30,
2007) - Tranzyme Pharma today announced the initiation of a Phase IIb
clinical
trial of its potent intravenous ghrelin agonist, TZP-101,
for the management of severe gastroparesis. TZP-101 is a first-in-
class
prokinetic agent under development for the treatment of
selected GI motility disorders. In July 2007, Tranzyme initiated
enrollment
in a Phase IIb clinical trial for post-operative ileus.
The severe gastroparesis Phase IIb trial, now underway in the
US,
Denmark and Sweden, is a multicenter, randomized, double-blind,
placebo-controlled, dose-ranging study to assess
the efficacy and
safety of TZP-101 in subjects suffering from severe diabetic
gastroparesis. The study has an adaptive
randomization design, and
could potentially enroll up to 100 subjects. The primary objective of
this study is to assess
the impact of TZP-101 on symptoms as defined
by a change from baseline in a validated gastroparesis symptom
scoring
assessment.
In July 2007, TZP-101 received fast track designation from the FDA
for the treatment of severe gastroparesis
based on Tranzyme's
positive Phase IIa clinical data. In the Phase IIa study, TZP-101 not
only demonstrated a statistically
significant increase in gastric
emptying (measured by scintigraphy) but also improved symptoms in 10
patients with long-standing
diabetes, poor glycemic control, and
significant gastropathy. Postprandial fullness, the most frequent and
severe symptom
observed with these patients, was reduced 37% by TZP-
101. This state-of-the-art simultaneous controlled investigation,
carried
out during euglycemic hyperinsulinemic clamp (in highly
selective homogenous patients), demonstrated for the first time
that
TZP-101 both accelerates gastric emptying of solid food and improves
symptoms characteristic of gastroparesis.
These observations clearly
suggest that TZP-101 is a potential break-through drug for the
management of severe gastroparesis.
Severe
gastroparesis is a cause of significant patient morbidity.
Frequent hospitalizations, emergency room and physician office
visits
may result from the difficulties in managing this disorder and its
diabetes-associated metabolic complications.
The impact on people's
lives, and the economic and resource burdens that gastroparesis
places on the healthcare system,
stresses the importance of
developing an effective and safe treatment for this indication. Most
current drug treatments
are only moderately effective at best, and
may cause neurological side effects.
"As of today, no efficient treatment
for diabetic gastroparesis
exists. The ability of TZP-101 to address both gastric emptying and
symptoms of gastroparesis
will potentially make this drug a unique
first-in-class treatment for this extremely difficult medical
condition," said
Dr. Niels Ejskjaer, principal investigator from the
Aarhus University Hospital, Denmark.
About TZP-101
TZP-101
is a potent, small molecule ghrelin receptor agonist that
Tranzyme is developing for the treatment of severe gastroparesis
and
post-operative ileus. The safety and pharmacokinetic profile of TZP-
101 has been characterized in 50 healthy subjects
across multiple
dose levels. The prokinetic properties of the compound have been well
established in various animal
models of postoperative ileus and more
recently in diabetic patients with severe gastroparesis. In addition
to TZP-101,
Tranzyme is developing an oral ghrelin agonist, TZP-102,
for the treatment of mild-to-moderate gastroparesis and other
chronic
GI motility disorders.
About Severe Gastroparesis
Gastroparesis is a paralysis of upper gastrointestinal
tract function
characterized by delayed gastric emptying in the absence of a
mechanical cause of obstruction. Disease
severity ranges from mild to
moderate to severe. Symptoms include post-prandial fullness,
bloating, nausea, vomiting,
and upper abdominal pain. Severe
gastroparesis, or gastroparesis with gastric failure, is
characterized by refractory
symptoms that are not controlled despite
medical therapy. Patients suffering from severe gastroparesis are
often unable
to maintain nutrition, or medication via oral delivery.
Because of their unremitting symptoms, they may be dependent on
gastric
suctioning and enteral/parenteral nutrition. Gastroparesis is
a major complication of diabetes. The World Health Organization
estimates
that 180 million people have diabetes. Approximately 5% of
Type 1 and 25% of Type 2 diabetic patients, or 13 million worldwide,
are
believed to suffer from gastroparesis. In addition, there may be
a nearly equal number of patients who suffer from gastroparesis
due
to other causes.
FDA DRUG REVIEW STEPS
1-Preclinical (animal) testing. Pre-IND
2-An investigational new drug application (IND) outlines what the sponsor of a
new drug proposes for human testing in clinical trials.
3-Phase 1 studies (typically involve 20 to 80 people).
4-Phase 2 studies (typically involve a few dozen to about 300 people).
5-Phase 3 studies (typically involve several hundred to about 3,000 people).
6-The pre-NDA period, just before a new drug application (NDA) is submitted. A
common time for the FDA and drug sponsors to meet.
7-Submission of an NDA is the formal step asking the FDA to consider a drug for
marketing approval.
8-After an NDA is received, the FDA has 60 days to decide whether to file it so
it can be reviewed.
9-If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's
research on the drug's safety and effectiveness.
10-The FDA reviews information that goes on a drug's professional labeling (information
on how to use the drug).
11-The FDA inspects the facilities where the drug will be manufactured as part
of the approval process.
12-FDA reviewers will approve the application or find it either "approvable"
or "not approvable."
*Spreading GP Awareness One
Person At A Time*
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