NEWTOWN,
Pa., July 31, 2024 /PRNewswire/ -- KVK Tech,
Inc. (KVK), a leading American developer, manufacturer, and
marketer of FDA-approved pharmaceuticals today announced the
successful registration of Lomaira™ (phentermine hydrochloride USP)
8 mg tablets, CIV in Mexico. This
registration is the result of a strategic partnership with
Productos Medix S.A. de C.V. ("Medix"), a leader in pharmaceutical
obesity products in Mexico. The
licensing agreement awarded Medix a license for the manufacture,
distribution, and marketing of Lomaira in Mexico.
KVK Tech, Inc. (KVK), today announced
the successful registration of Lomaira™ in Mexico.
Lomaira is an appetite suppressant available by prescription
only and used for a short period of time for weight reduction in
adults with an initial body mass index (BMI) of 30 or more or 27 or
more with a weight-related condition such as controlled high blood
pressure, diabetes, or high cholesterol. BMI measures the amount of
fat in the body based on height and weight and is measured in
kg/m2. Lomaira should be used together with increased
physical activity and a reduced-calorie diet. Please see full
prescribing information for Lomaira
at www.lomaira.com.
"According to the WHO, Mexico
has the 2nd highest prevalence of Overweight and Obesity
worldwide. At Medix, we continue to innovate with solutions to
treat the burden of the disease, and its negative impact on the
quality of life of people living with Obesity. Our extensive
portfolio continues to innovate with options like Lomaira, to
support our vision." Statement by Gerardo de Eguiluz, Sr Dir
Business Development Medix
"We're thrilled for Medix to launch Lomaira in Mexico and help tackle the unmet needs in the
global obesity epidemic," said Kiran Vepuri, Vice President of
Business Development at KVK. "Obesity is not just an American
problem and we aspire to help patients worldwide."
Lomaira is a low dose of the #1 prescribed medication for weight
loss in the US with over 60 years of real-world experience
(phentermine HCl).
IMPORTANT SAFETY INFORMATION
Don't take Lomaira™ if you have a history of
cardiovascular disease (e.g., coronary artery disease, stroke,
arrhythmias, congestive heart failure or uncontrolled high blood
pressure); are taking or have taken a monoamine oxidase inhibitor
drug (MAOI) within the past 14 days; have overactive thyroid,
glaucoma (increased pressure in the eyes), agitation or a history
of drug abuse; are pregnant, nursing, or allergic to the
sympathomimetic amines such as phentermine or any of the
ingredients in Lomaira.
Taking phentermine with other drugs for weight loss is not
recommended. Primary pulmonary hypertension (PPH), a rare fatal
lung disease, has been reported in patients who had taken a
combination of phentermine and fenfluramine or dexfenfluramine for
weight loss. The possible association between phentermine use alone
and PPH cannot be ruled out. Patients should report immediately if
they experience any decrease in the amount of exercise that they
can normally tolerate, shortness of breath, chest or heart pain,
fainting or swelling in the lower legs.
Serious heart valve problems or disease have been reported in
patients taking a combination of phentermine and fenfluramine or
dexfenfluramine for weight loss. The possible role of phentermine
has not been established, therefore the possibility of an
association between heart valve disease and the use of phentermine
alone cannot be ruled out.
If your body becomes adjusted to the maximum dose of phentermine
so that its effects are experienced less strongly, the maximum dose
should not be exceeded in an attempt to increase the effect.
Caution is advised while engaging in potentially hazardous
activity such as driving or operating machinery while taking
phentermine. Phentermine has the potential to be abused. Keep
Lomaira in a safe place to prevent theft, accidental overdose,
misuse or abuse. Using alcohol with phentermine may result in an
adverse drug reaction.
Phentermine can cause an increase in blood pressure. Tell your
doctor if you have high blood pressure, even if it's mild. If you
are taking medicines for type 2 diabetes, your doctor may have to
adjust these medicines while taking phentermine.
Some side effects of phentermine that have been reported include
pulmonary hypertension, valvular heart disease, palpitations,
increased heart rate or blood pressure, insomnia, restlessness, dry
mouth, diarrhea, constipation and changes in sexual drive. These
are not all of the potential side effects of phentermine. For more
information, ask your doctor or pharmacist.
To report negative side effects of prescription drugs, contact
FDA at 1-800-FDA-1088 or
visit www.fda.gov/medwatch.
See Full Prescribing Information
at www.lomaira.com.
About KVK Tech
KVK is a leader in the development and manufacture of
high-quality, FDA-approved medicines that address unmet patient
needs. Founded in 2004, KVK takes pride in its ability to advance
medical care and offer low-cost alternatives in response to today's
healthcare challenges. All of KVK's products are made in
the U.S.A. in a state-of-the-art facility
in Newtown, PA. KVK is committed to maintaining its
entire business operations in America, as it continues to build
strong, lasting relationships with the nation's largest pharmacy
chains, wholesalers and distributors.
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SOURCE KVK Tech, Inc.