"KVK Tech Inc. announced today that the U.S. Food and Drug Administration FDA has approved Lomaira phentermine hydrochloride USP  mg tablets CIV a lowcost lowdose prescription medicine used for a short period of time a few weeks for weight reduction in adults with an initial body mass index BMI of  or more obese or  or more overweight with at least one weightrelated condition such as controlled high blood pressure diabetes or high cholesterol. Lomaira should be used together with regular exercise and a reducedcalorie diet.  Lomaira is the only strength of phentermine hydrochloride that can be taken up to three times a day before meals. The limited usefulness of agents of this drug class anorectics including Lomaira should be measured against possible risk factors inherent in their use.  At KVK Tech we are committed to developing highquality FDAapproved medicines that address unmet medical needs while ensuring affordable options for all appropriate patients. With Lomaira were giving physicians and patients access to a lowcost lowdose version of a weightreduction medicine phentermine that has been prescribed by physicians for over  years. Appropriate patients can take Lomaira up to three times a day before meals  not just in the morning as with the higher dose formulations of phentermine said Anthony Tabasso President and Chief Executive Officer of KVK Tech. We developed Lomaira with this dosing flexibility and affordability in mind. Phentermine hydrochloride an appetite suppressant is the most commonly prescribed drug for weight loss. Over  million prescriptions are written for phentermine yearly by a wide range of healthcare professionals HCPs including obesity medicine specialists family practitioners endocrinologists internists and cardiologists.    Phentermine hydrochloride is typically prescribed in doses ranging from  to . mg and taken before or within a few hours of breakfast. The usual adult dose of Lomaira is one tablet three times a day  hour before meals. The butterflyshaped tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose enabling doctors and patients to work together to customize a weightloss treatment plan to best meet each patients needs. Dosage should be individualized to obtain an adequate response with the lowest effective dose. Phentermine is not recommended for use in pediatric patients  years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.  Lomaira is reasonably priced to ensure that cost does not create a hurdle despite the fact that twothirds of Americans pay outofpocket for their weightloss prescription medications. Through KVK Techs Lomaira LoCost Access Program eligible patients will pay no more than  per tablet for the duration of treatment.  Obesity is a chronic metabolic disease that must be managed appropriately to reduce the risk of serious health conditions. Many physicians have used phentermine to help patients as part of a comprehensive weightmanagement plan. Now the flexibility in dosing with Lomaira allows doctors to personalize dosing.  They can prescribe a lower dose a good option for some patients. They can also prescribe up to three times a day which is particularly helpful when patients struggle to control their appetite in the afternoon said Donna Ryan MD. Regrettably many patients are still not covered by insurance for weightloss medications and the low cost for Lomaira makes it an affordable treatment option.   In relatively shortterm clinical trials adults with obesity who were instructed in dietary management and treated with anorectic drugs appetite suppressants lost more weight on the average than those treated with placebo and diet. It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions or metabolic effects may also be involved.  Even modest weight loss can dramatically improve risk and health continued Dr. Ryan. It is not necessary to lose a lot of weight to get a lot of benefit. Losing five to  percent of total body weight is likely to produce health benefits such as improvements in blood pressure blood cholesterol and blood sugars. 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. See Full Prescribing Information.  Lomaira is anticipated to be available by the end of September . As with all KVK Tech products Lomaira will be exclusively manufactured and packaged in the United States in the strictest accordance with FDA DEA and DEP guidelines.  Body Mass Index BMI measures the amount of fat in the body based on height and weight. BMI is measured in kgm.  REFERENCES  Data on file. KVK Tech Inc. Newtown PA   Lomaira Package Insert  Benefits of Modest Weight Loss in Improving Cardiovascular Risk Factors in Overweight and Obese Individuals With Type  Diabetes Diabetes Care July  http Rena R. Wing Wei Lang Thomas A. Wadden Monika Safford William C. Knowler Alain G. Bertoni James O. Hill Frederick L. Brancati Anne Peters Lynne Wagenknecht and the Look AHEAD Research Group IMPORTANT SAFETY INFORMATION   Dont take LomairaTM 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  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 its mild. If you are taking medicines for type  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 FDA or visit  http Click here for Full Prescribing Information. httporiginqps.onstreammedia.comoriginmultivu_archiveENRLomairaFullPrescribingInformation.pdf About KVK Tech  KVK is a leader in the development and manufacture of highquality FDAapproved medicines that address unmet patient needs.  Founded in  KVK takes pride in its ability to advance medical care and offer lowcost alternatives in response to todays healthcare challenges. All of KVKs products are made in the U.S.A. in a stateoftheart 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 nations largest pharmacy chains wholesalers and distributors.  Media Contact  Ellie Polack Edelman Office  Cell  K SOURCE KVK Tech Inc."