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Publication Date: March 2008
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NEW DRUGS APPROVED IN
2007

Qin Dong, Pharm. D. Candidate



Discovering and developing safe and effec-
tive new medications is a time-consuming, difficult,
and expensive process. On average, it takes 8.5
years to develop a new drug. Starting from early
laboratory and animal testing to general public appli-
cation, the drug review process has 12 separate steps.
Included within this process are the preclinical
(animal) testing, phase 1 studies (20 to 80 people),
phase 2 studies (a few dozen to 300 people), and
phase 3 studies (several hundred to about 3,000 peo-
ple). 1
In 2007, 18 new drugs made their debut, in-
cluding 16 new molecular entities and 2 new deriva-
tives. Also, there were 30 new drugs approved with
significantly new dosage forms from previously ap-
proved drugs. A summary of drug names, pharma-
cokinetic and pharmacodynamic properties, dose and
administration, estimated cost, and approval dates
are listed in Table 1.
This article will discuss the most significant
new molecular entities, new derivatives, and new
formulations in alphabetical order based on brand
names.
Retapamulin (AltabaxR) is a topical antibiotic
ointment approved for the treatment of impetigo due
to methicillin-susceptible S. aureus or S. pyogenes in
patients 9 months of age or older. It inhibits normal
bacterial protein biosynthesis by binding at protein


L3 on the ribosomal 50s subunit. The most common
adverse reaction associated with the topical applica-
tion of retapamulin is skin irritation (1.4%).2,3
Parish et al. compared topical retapamulin
ointment twice daily to oral cephalexin 500 mg twice
daily in 546 patients with secondarily infected der-
matitis.4 The investigators found that 85.9% of re-
tapamulin-treated patients and 89.7% of patients who
received oral cephalexin had similar clinical success.
The authors concluded that retapamulin ointment
administered twice daily for 5 days was at least as
effective as 10 days of twice daily oral cephalexin
for the treatment of secondarily infected traumatic
skin lesions.
Retapamulin is the first agent in a new pleu-
romutilin class. It has no cross-resistance with other
antibiotics such as beta-lactams, macrolides, fusidic
acid and mupirocin. It may be an option in patients
where 10 days of oral cephalexin or topical mupiro-
cin are difficult to complete, but it should be avoided
in patients with more extensive impetigo and those
with systemic symptoms.
Nebivolol (Bystolic) is a third generation
selective 3P-blocker approved for the treatment of
hypertension (HTN). Mechanisms of action include
decreased heart rate, decreased myocardial contrac-
rIa U I


mm


A9 PharmaNote


VOLUME 23, ISSUE 6 MARCH 2008


INSIDE THIS ISSUE:
NEW DRUGS APPROVED IN 2007


Volume 23, Issue 6 March 2008


PharmaNote






utility, diminution of tonic sympathetic outflow to the
periphery from cerebral vasomotor centers, and sup-
pression of renin activity. In addition to the P-
blocking activity, nebivolol also modulates the en-
dogenous production of nitric oxide resulting in pe-
ripheral vasodilation. The most common side effects
of nebivolol include headache (6-9%), dizziness (2-
4%), somnolence, and nausea (1-3%).2,3
Van Neuten et al. compared nebivolol 5 mg
and atenolol 50 mg to placebo in a randomized, dou-
ble-blind, parallel-group trial in 364 patients with
established HTN and found both active drugs caused
significant and similar reduction in systolic and dia-
stolic pressures without orthostatic effect.5 Another
multicenter, randomized, double-blind trial also con-
ducted by Van Neuten studied nebivolol 5 mg once
daily compared to enalapril 10 mg once daily in the
treatment of essential HTN.6 Nebivolol 5 mg was
superior to 10 mg enalapril in changes of sitting dia-
stolic pressure at trough level from baseline. Grassi
et al. evaluated nebivolol 5 mg versus atenolol 100
mg.7 HCTZ 12.5 mg was added in patients with
blood pressure higher than 140/90 mm Hg. The au-
thors concluded that both agents significantly de-
creased sitting systolic blood pressure (SBP) and dia-
stolic blood pressure (DBP) from baseline.
Compared to other P-blockers, nebivolol has
very high P-1 specificity, favorable side effect pro-
file, and long duration of action. Nebivolol is a once
daily medication that can be used alone or in combi-
nation with other hypertension treatments.
Doripenem (Doribax) is a broad-spectrum,
intravenous, carbapenem antimicrobial agent. It in-
hibits the third and final stage of bacterial cell wall
synthesis and facilitates bacterial cell lyses by inacti-
vating essential penicillin-binding proteins. The most
common side effects include headache (4-16%), diar-
rhea (6-11%), phlebitis (4-8%), and rash (4-8%).2,3
Solomkin et al. compared doripenem (n=486)
to meropenem in a randomized trial with an option
for oral step-down therapy with amoxicillin/
clavulanate in the treatment of complicated intra-
abdominal infections (clAI).8 The authors concluded
that doripenem was generally safe and non-inferior to
meropenem in clAI. Naber and colleagues evaluated
IV doripenem versus IV levofloxacin in the treatment
of complicated urinary tract infections (cUTI) in
DORI-5 trial.9 The authors concluded that
doripenem was non-inferior to levofloxacin in cUTI
and the use of doripenem was generally well toler-


ated. Rea-Neto et al. found doripenem was therapeu-
tically non-inferior to piperacillin/tazobactam in the
treatment of hospitalized patients with nosocomial
pneumonia. 10
The efficacy and coverage of doripenem are
similar to meropenem with the possible exception of
enhanced pseudomonal coverage based on in vitro
activity (1 MIC dilution lower). Due to potential re-
sistance, doripenem should be reserved for the treat-
ment of complicated urinary tract infections, compli-
cated intra-abdominal infections, and in multi-drug
resistant infection where bacteria are more suscepti-
ble to doripenem.
Sapropterin (KuvanR) is an orphan drug ap-
proved to slow the effects of a rare genetic, meta-
bolic disorder in patients with hyperphenylalanine-
mia (HPA) due to tetrahydrobiopterin-(BH4) respon-
sive phenylketonuria (PKU). It works by activating
residual phenylalanine hydroxylase (PAH) enzymes
and reducing blood phenylalanine (Phe) levels. The
most common adverse events are headache, diarrhea,
abdominal pain, upper respiratory tract infection, and
throat pain. 2,3
Burton et al. concluded that sapropterin was
well tolerated and reduced blood Phe levels across
all PKU phenotypes based on an 8-day course of sap-
ropterin (10 mg/kg per day) in 490 patients with
PKU.11 Levy et al. conducted a multicentre, random-
ized, double-blind, placebo-controlled trial in 89 pa-
tients with PKU.12 The mean blood Phe in control
group fluctuated only slightly from baseline over 6
weeks; whereas in the sapropterin group, the mean
blood phenylalanine concentration fell from 843
mmol/1 to 619.9 mmol/1 after one week of treatment
with sapropterin (10 mg/kg/day); the reduced con-
centration remained throughout the 6 weeks of sap-
ropterin treatment.
With the combination of a phenylalanine-
restricted diet, sapropterin is an effective therapy in
selected patients with HPA and mild-to-moderate
PKU who responded to a BH4 loading test. Patients
being treated with sapropterin must have their blood
Phe levels monitored frequently.
Ambrisentan (Letairis) is an endothelin re-
ceptor antagonist (ERA) indicated for the once daily
oral treatment of pulmonary arterial hypertension
(PAH) in patients with WHO class II or III symp-
toms. It blocks vasoconstriction and cell prolifera-
tion effects of endothelin-A in vascular smooth mus-
cle and endothelium, which in turn relaxes the blood


PharmaNote Volume 23, Issue 6 March 2008


Volume 23, Issue 6 March 2008


PharmaNote







vessels and reduces right atrial pressure in patients
with PAH. The most common side effects are pe-
ripheral edema (17%), headache (15%), and de-
creased hemoglobin (7-10%).2,3
Oudiz and colleagues conducted a 12-week
study (ARIES-1) which compared daily doses of 5
mg and 10 mg ambrisentan to placebo in 202 patients
with PAH.13 ARIES-2, investigated by Olschewski
et al, was conducted in 192 patients with PAH for 12
weeks.14 The study compared daily doses of 2.5 mg
and 5 mg ambisentan to placebo. Both studies
showed that treatment with ambrisentan resulted in a
significant improvement in 6-minute walking dis-
tance for each dose and the dose-response relation-
ship became apparent after 12 weeks of treatment.
Moreover, there was a significant delay in the time to
clinical worsening for patients receiving ambrisentan
compared to placebo. The long-term follow-up of
patients who were treated with ambrisentan in the
two pivotal studies and their open-label extension
(N=383) showed that 95% were still alive at one year
and 94% were still receiving ambrisentan monother-
apy.
Compared to bosentan, ambrisentan is well
tolerated with a lower incidence and severity of liver
function test abnormality. However, because of the
possibility of liver injury and birth defects, ambrisen-
tan is available only through the Letairis Education
Access Program (LEAP) by calling 1-866-664-LEAP
(5327) or by logging on to www.letairis.com.
Rotigotine (NeuproR) is the first transdermal
non-ergolinic dopamine agonist, indicated once-daily
for the treatment of early-stage Parkinson's disease
(PD). The exact mechanism is unknown, but it may
stimulate D2 receptors within the caudate-putamen
in the brain. 2,3
Watts et al. evaluated the efficacy of roti-
gotine in a randomized, double-blind, multinational
study on 277 early-stage idiopathic PD patients.
They found a statistically significant difference in
Unified Parkinson's Disease Rating Scale (UPDRS)
scores between the placebo and rotigotine.15 The
Parkinson Study Group conducted an international,
randomized, double-blind trial with 242 early-stage
PD and found the minimum effective dose was 4-6
mg/24 hours. 16 Poewe and colleges compared the
efficacy of transdermal rotigotine to pramipexole
(Mirapex) in levodopa-treated advanced PD pa-
tients (N=506) in a randomized, double-blind, con-
trolled trial.17 Rotigotine was non-inferior to


pramipexole in change of absolute off-time from
baseline.
Compared to other dopamine agonists, roti-
gotine offers a valuable therapeutic alternative as
monotherapy for early-stage PD patients and possi-
ble combination therapy with levodopa/carbidopa in
advanced PD patients by providing constant blood
levels over a 24- hour period.
Aliskiren (TekturnaR) is a direct renin inhibi-
tor indicated for the once-daily, oral treatment of
HTN. It binds to a pocket in the renin molecule,
blocking angiotensinogen cleavage. Aliskiren ap-
pears to be well tolerated. Some side effects associ-
ated with aliskiren include rash (1%) and cough
(1.1%).2,3
Mitchell et al. demonstrated a statistically
significant change from baseline in 24-hour mean
ambulatory DBP and SBP with ariskiren 150 mg,
300 mg, or 600 mg compared to placebo in a ran-
domized trial with 2776 patients > 18 years of age
with mild-to-moderate HTN.18 Villamil et al. con-
cluded that aliskiren monotherapy was superior to
placebo in reducing mean sitting diastolic blood
pressure (MSDBP) and mean sitting systolic blood
pressure (MSSBP). In combination with HCTZ, al-
iskiren provided significant additional blood pressure
reduction.19 Pool et al. showed that coadministration
of aliskiren and valsartan produced a greater anti-
hypertensive effect than either drug alone, compara-
ble in magnitude to the effect of valsartan/
hydrochlorothiazide.20 O'Brien et al. also concluded
that the addition of 75 or 150 mg of aliskiren to 150
mg of irbesartan alone, for 3 weeks, resulted in sig-
nificantly lower nighttime pressures compared with
irbesartan monotherapy.21
Based on these published trials, ariskiren ap-
pears to be effective for the treatment of hyperten-
sion.
Fluticasone furoate (Vem.iny,) is a newly
approved corticosteroid nasal spray for seasonal and
perennial allergic rhinitis. Compared to fluticasone
propionate (Flonase), fluticasone furoate is indi-
cated for patients as young as 2 years old, has once-
daily dosing, is scent-free, and delivers a consistent
dose in a gentle-fine mist. However, fluticasone fu-
roate costs more than generic fluticasone propionate,
and no evidence supports fluticasone furoate is more
efficacious than fluticasone propionate. 2,3
Lisdexamfetamine (Vyvanse) is an ampheta-
mine derivative prodrug used for treating attention-


PharmaNote Volume 23, Issue 6 March 2008


Volume 23, Issue 6 March 2008


PharmaNote







deficit/hyperactivity disorder (ADHD). It is rapidly
absorbed and converted to dextroamphetamine by
intestinal or first-pass liver metabolism. The exact
mechanism of dextroamphetamine is unknown, but it
may block the reuptake of norepinephrine and dopa-
mine. The most common side effects of lisdexamfe-
tamineare loss of appetite (39%), insomnia (19%),
and headache (12%).2,3
In a randomized, double-blind, placebo- and
active-controlled crossover study comparing the effi-
cacy and safety of lisdexamfetamine with placebo in
52 children ages 6 to 12 years with ADHD, Lopez et
al. found 74% of lisdexamfetamine patients and 72%
of mixed amphetamine salts extended-release pa-
tients "very much improved" or "much improved"
using the Clinical Global Impressions score.22 Both
drugs showed similar improvement and adverse
events versus placebo. In a multi-center, placebo-
controlled trial, Biederman et al. assessed the effi-
cacy and tolerability of lisdexamfetamine in 290
school-aged children with ADHD.23 The treatment
with lisdexamfetamine 30 to 70 mg for 4 weeks re-
sulted in improvement in ADHD Rating Scales and
Conner's Parent Rating Scale.
Lisdexamfetamine is a Schedule II controlled


substance. There's no evidence that lisdexamfeta-
mine is more effective or causes fewer side effects
than Adderall XR.
Levocetirizine (Xyzalr) is an oral antihista-
mine approved for the relief of symptoms associated
with idiopathic urticaria and seasonal and perennial
allergic rhinitis in adults and children age 6 years and
older. Levocetirizine, the R-enantiomer of cetirizine,
is a selective piperazine Hi- receptor antagonist.
Clinical data has not demonstrated that levocetirizine
is more efficacious than other antihistamines. Levo-
cetirizine may be helpful for patients whose allergic
symptoms are not controlled by other antihista-
mins.2'3

References
1. The FDA's Drug Review Process: Ensuring Drugs
Are Safe and Effective http://www.fda.gov/
2. Clinical pharmacology. Gold Standard Inc. 2008.
3. Micromedex Healthcare Series.
4. Parish LC, Jorizzo JL, Breton JJ, et al. Topical retapa-
mulin ointment (1%, wt/wt) twice daily for 5 days
versus oral cephalexin twice daily for 10 days in the
treatment of secondarily infected dermatitis. J Am
Acad Dermatol 2006;55:1003-13.
5. Van Neuten L, Taylor FR, and Robertson JIS. Ne-


Table 1. Summary of the most significant new molecular entities, new derivatives, and new formulations2'3
Brand Generic PKa/PDb Dose/Administration Estimated Costg Approval
Date
New molecular entities
A': increased when applied to abraded
skin Apply a thin layer 5 g tube: $41.02
Altabax retapamulin Dd: 94% protein binding topically twice daily 10 g tube: $69.52 4/07
Me: hepatic via CYP 3A4 for 5 days 15 g tube: $68.60
No significant effect on QT interval
A': 12% bioavailability in extensive HTN: 5 mg orally
HTN: 5 mg orally
metabolizers (EMs) to 96% bioavail- daily, titrate at 2-week
daily, titrate at 2-week
ability in poor metabolizers (PMs), ntrv t2.5 mg (30- day):
food has insignificant effect inals t 4 $66.59
Dd: 98% protein binding daily 5 mg (30- day):
ytoric neivlo Dd 10 prote.in bindin ~ Heart failure: 1.25 mg 58 12/07
Bystolic nebivolol Me: hepatic via direct glucuronidation ray aily traed $58.59 12/07
orally daily titrated to
and N-dealkylation and oxidation by 10 mg (30- day):
CYP2D6 a maximum of 10 mg $58.59
Ef: 38% in urine and 44% in feces daily (non-FDA ap-
proved indication)
(Ems), 67% in urine and 13% in feces proved indication)
(PMs)
D': 8.1% protein binding
Doribax do Me: non-hepatic, 15% converted to IV, 500 mg Q 8 hours, AWPh of 500 mg 10
inactive metabolites in kidney administer over 1 hour vial: $47.91
Ef: 70% unchanged drug in kidney

A': Food increases AUC by 87% and For 70kg, 700mg
Kuvan sapropterin C by 84 Oral, 10 mg/kg/day to (30-day): $7,617.50 12
t12is 6.7 hours 20 mg/kg/day and 1400mg (30-
t/2 is 6.7 hours day): $15,200
day): $15,200'

PharmaNote Volume 23, Issue 6 March 2008







Table 1 (continued).


Brand Generic PKa /PDb Dose/Administration Estimated Costg Approval
Date

New molecular entities


ambrisen-
tan


A': unknown bioavailability, food
has no effect

Dd: 99% protein binding

Me: hepatic through CYP3A4,
CYP2C19, UGT-1A9S, 2B7S
Ef: Non-renal: predominant
No significant QT prolongation


Oral with or without food
Initial: 5 mg daily; if toler-
ated, may increase to maxi-
mum of 10 mg daily


5 mg (30-day):
$4829.99
10 mg (30-day):
$4829.99


A': food has no effects
Dd: 89.5% protein binding
Neupro rotigotine Me: N-dealkylation and conjuga-
tion at liver
Ef: 70% renal

A': poorly absorbed, decreased
with high fat meal
Tekura a Dd: protein binding 49.5%
Tekurna aliskiren
Me: in vitro via CYP3A4
Ef: 91% eliminated unchanged
through feces

A': fast absorption
lisdexam- Dd: CNS, plasma, and breast milk
Vyvanse fetamine Me: intestinal/hepatic: first-pass
metabolism
Ef: Renal 96%


Flictoi


Diclofenac epolamine






Fluticasone furoate


\V [,III% Sl


Transdermal,
2 mg/24hours to 6 mg/24
hours



Take consistently with or
without food
Initial 150 mg/day orally,
may increase to 300 mg/
day


All patients > 6 yrs start at
30 mg orally daily, may
increase by 20 mg/day at
weekly intervals to a maxi-
mum of 70 mg/day


New derivatives
Apply one 1.3% topical
patch (180 mg) to the most
painful site BID


For 12 yrs and older, 110
mcg daily, delivered as two
sprays to each nostril.
For children 2 to 11 yrs, 55
mcg daily, delivered as one
spray to each nostril


2 mg/24 hour (30-
day): $120.89
4-6 mg/24 hour (30-
day): $369.90



150 mg (30-day):
$69.99
300 mg (30-day):
$87.99


30 mg (30-day):
$135.99
50 mg (30-day):
$135.99
70 mg (30-day):
$135.99


$ 10.99 per 1.3% topi-
cal patch






$ 108.99 per bottle


Newformulations


Levocetirizine


For 12 yrs and older, 5 mg
once every evening.
For children 6 to 11 yrs, 2.5
mg once every evening.


5 mg (30-day): $97.59


aPK= pharmacokinetics; bPD= pharmacodynamics; CA = absorption; dD distribution; eM= metabolism; E = elimination; Estimated Costg obtained from the average
of 5 different retail pharmacy stores; hAWP average wholesale price from the Red Book, manufacturer's information and the McKesson database. Kuvan price'
obtained from Fairview specialty pharmacy, one of the specialty pharmacies distributes Kuvan
P h ar m a___teV olu me_2 3,_ Iss ue_6_M arch_2 0 0 8


6/07


5/07






3/07







2/07


1/07






4/07


X A/,l


Volume 23, Issue 6 March 2008


PharmaNote







bivolol vs atenolol and placebo in essential hyperten-
sion: a double-blind randomized trial. J Hum Hyper-
tens 1998;12:135-140.
6. Van Neuten L, Schelling A, et al. Nebibolol vs enala-
pril in the treatment of essential hypertension: a dou-
ble-blind randomized trial. J of Hum Hypertens
19971;11:813-19.
7. Grassi G, Trevano FQ, et al. Efficacy and tolerability
profile of nebivolol vs atenolol in mild-to-moderate
essential hypertension: results of a double-blind ran-
domized multicentre trial. Blood Press Suppl
2003;2:35-40.
8. Solomkin J, Umeh O, Jiang J, et al. Doripenem versus
meropenem ith an option for oral step-down therapy
in the treatment of complicated intra-abdominal infec-
tions. [Poster] Presented at the 47th ICAAC, Chicago,
IL, September 17-20, 2007.
9. Naber K, Redman R, Kotey P, et al. IV therapy with
doripenem vs. levofloxacin with an option for oral
step-down therapy in the treatment of complicated
urinary tract infection and pyelonephritis. [abstract
1733-331]. Presented at the 17th ECCMID, Munich,
Apr 1-4, 2007.
10. Rea-Neto A, Niederman M, Lee M, et al. Efficay and
safety of intravenous doripenem vs. piperacillin/
tazobactam in nosocomial pneumonia [Poster]. Pre-
sented at the 47th ICAAC; Chicago, IL; Sept.17-20,
2007.
11. Burton BK, Grange DK, et al. The response of pa-
tients with phenylketonuria and elevated serum
phenylalanine to treatment with oral sapropterin dihy-
drochloride (6R-tetrahydrobiopterin): a phase II, mul-
ticentre, open-label, screening study. J Inherit Metab
Dis 2007;30: 700-7.
12. Levy HL, Milanowski A, et al. Efficacy of saprop-
terin dihydrochloride (tetrahydrobiopterin, 6R-BH4)
for reduction of phenylalanine concentration in pa-
tients with phenylketonuria: a phase III randomised
placebo-controlled study. Lancet 2007;370: 504-10.
13. Oudiz RJ, Torres F, Frost AE et al. ARIES-1: A pla-
cebo-controlled, efficacy and safety study of ambris-
entan in patients with pulmonary arterial hyperten-
sion. Chest 2006;130: 121S.
14. Olschewski H, Galie N, Kramer M et al. Ambrisentan
Improves Exercise Capacity and Time to Clinical
Worsening in Patients with Pulmonary Arterial Hy-
pertension: Results of the ARIES-2 Study. San Diego,
CA: American Thoracic Society, 2006.
15. Watts RL, Jankovic J, Waters C, et al. Randomized,
blind, controlled trial of transdermal rotigotine in
early Parkinson disease. Neurology. 2007;68:272-6.
16. The Parkinson Study Group. A controlled trial of roti-
gotine monotherapy in early Parkinson's disease.
Arch Neurol 2003:60:1721-8.
17. Poewe WH, Rascol O, Quinn N, et al. Efficacy of


pramipexole and transdermal rotigotine in advanced
Parkinson's disease: a double-blind, double-dummy,
randomised controlled trial. Lancet Neurology
2007;6:513-20.
18. Mitchell J, Oh B, Herron J, et al. Once-daily aliskiren
provides effective, smooth 24-hour control in patients
with hypertension. J Clin Hypertension. 2006;8:A93.
Abstract P-209.
19. Villamil A, Chrysant SG, Calhoun D, et al. Renin
Inhibition with aliskiren provides additive antihyper-
tensive efficacy when used in combination with
HCTZ. J Hypertension 2007; 25: 217-26
20. Pool J, Schmieder R, et al. Aliskiren, an orally effec-
tive renin inhibitor, provides antihypertensive effi-
cacy alone and in combination with valsartan. Am J
Hypertension 2007;20:11-20.
21. O'Brien E, et al. Aliskiren reduces blood pressure and
suppresses plasma renin activity in combination with
a thiazide diuretic, an angiotensin converting enzyme
inhibitor, or an angiotensin receptor blocker. Hyper-
tension 2007;49:1-9.
22. Lopez FA, Boellner SW, Childress A, et al. ADHD
improvement in children treated with lisdexamfeta-
mine dimesylate (LDX; NRP 104) and MAS XR.
Program and abstracts of the 19th U.S. Psychiatric &
Mental Heath Congress; November 15-19, 2006; New
Orleans, LA. Abstract 103.
23. Biederman, J, Krishnan, S, Zhang, Y, et al. Efficacy
and tolerability of lisdexamfetamine dimesylate
(NRP-104) in children with attention-deficit/
hyperactivity disorder: a phase III, multicenter, ran-
domized, double-blind, forced-dose, parallel-group
study. Clin Ther 2007;29:450.


PharmaNote Volume 23, Issue 6 March 2008


The PharmaNote is Published by:
The Department of Pharmacy
Services, UF Family Practice Medical
Group, Departments of Community
Health and Family Medicine and
Pharmacy Practice
University of Florida


John G. Gums Editor
Pharm.D.

R. Whit Curry, M.D. Associate Editor

Shawn Anderson Assistant Editor
Pharm.D.

_ _ _ _ _ _


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PharmaNote




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