Generic version of popular birth control combo pill gets FDA nod. The United States Food and Drug Administration on April 9 approved the abbreviated new drug application (ANDA) of Glenmark Generics Inc., USA, to produce norgestimate and ethinyl estradiol tablets USP, 0.25 mg/0.035 mg.
The combination hormonal birth control tablet is a generic version of the popular Ortho Cyclen tablets produced by Janssen Pharmaceuticals, Inc. and used to prevent pregnancy. Birth control pills that contain norgestimate are the only ones FDA has approved to help reduce acne, and the new generic norgestimate and ethinyl estradiol tablets are also indicated for the treatment of severe acne.
The tablets contain a combination of female hormones that prevent ovulation — or the release of an egg from an ovary. The combo pill also works by causing changes in the cervical mucus and uterine lining of women, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Newer drugs like norgestimate-ethinyl estradiol tablets aren’t any more effective than older pills that used a combination of estrogen and progestin to stop ovulation and help block sperm — both types of pills allow one unplanned pregnancy per year for every 100 women. But the newer class of drugs appear to reduce bloating and mood swings, which are common side effects of older pills. This is mainly because norgestimate, a third-generation progestin, has high progestational activity while showing slight estrogenic effects and tends to be less androgenic.
The hormone combination pill is also marketed under the brand names Mononessa, Norgestimate, Ortho Tri-Cyclen Lo, Previfem, Sprintec, Tri-Previfem, Tri-Sprintec or TriNessa.
Norgestimate and ethinyl estradiol tablets USP, 0.25 mg/0.035 mg racked up total market sales of approximately US$88 million, according to IMS Health for the 12-month period ending December 2011.
Under its abbreviated system or ANDA, the FDA allows drugmakers to gain approval for the drugs they develop in a process that is speedier than the usual. ANDAs are granted to developers of drugs for rare conditions because these drugs aren’t likely to be very profitable.
They are also granted to generic versions of branded drugs that have already been approved. Under such abbreviated generic drug applications, drug manufacturers are required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must simply demonstrate scientifically that their product is bioequivalent — or performs in the same manner as the innovator drug.
Glenmark USA, a subsidiary of Glenmark Generics Ltd., is a specialist in hormonal products, and the approval of the generic norgestimate-ethinyl estradiol tablets is its tenth female hormonal product has been approved by the FDA. The company’s current portfolio consists of 79 generic products and 39 pending ANDAs awaiting federal approval.
Norgestimate and ethinyl estradiol tablets do’s and don’ts
Important Information
DON’T use norgestimate-ethinyl estradiol tablets if you are pregnant or if you have recently had a baby.
DO know that:
•Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.
•You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Norgestimate-ethinyl estradiol tablets.
•Some drugs can make norgestimate-ethinyl estradiol tablets less effective — which may result in pregnancy. DO tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. DON’T start using a new medication without telling your doctor. DO follow your doctor’s instructions.
•Norgestimate-ethinyl estradiol tablets can cause birth defects. DON’T use if you are pregnant. DO tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least four weeks before taking norgestimate-ethinyl estradiol tablets (six weeks if you are breast-feeding).
•The hormones in norgestimate-ethinyl estradiol tablets can pass into breast milk and may harm a nursing baby. Norgestimate-ethinyl estradiol tablets may also slow breast milk production. DON’T use norgestimate-ethinyl estradiol tablets if you are breastfeeding a baby.
DON’T use norgestimate-ethinyl estradiol tablets if you have any of the following conditions:
•a history of stroke or blood clot
•circulation problems
•migraine headaches
•abnormal vaginal bleeding
•a hormone-related cancer such as breast or uterine cancer
•liver disease or liver cancer
•or a history of jaundice caused by birth control pills
Before taking norgestimate and ethinyl estradiol tablets
Before using Norgestimate-ethinyl estradiol tablets, DO tell your doctor if you have any of the following conditions — you may need a dose adjustment or special tests to take norgestimate-ethinyl estradiol tablets safely:
•High blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack
•High cholesterol or if you are overweight
•A history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram
•A history of depression
•Gallbladder disease
•Seizures or epilepsy
•Diabetes
•A history of irregular menstrual cycles
When taking norgestimate and ethinyl estradiol tablets
DO take Norgestimate-ethinyl estradiol tablets exactly as it was prescribed for you.
DON’T take larger amounts, or take it for longer than recommended by your doctor.
DO take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor’s instructions).
DO know that the 28-day birth control pack contains seven “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
DO take one pill every day — no more than 24 hours apart. When the pills run out, DO start a new pack the following day. You may get pregnant if you don’t use Norgestimate-ethinyl estradiol tablets regularly.
DO get your prescription refilled before you run out of pills completely.
DO know that if you need to have any type of medical tests or surgery — or if you will be on bed rest — you may need to stop using norgestimate-ethinyl estradiol tablets for a short time. DO know that any doctor or surgeon who treats you should know that you are using norgestimate-ethinyl estradiol tablets.
DO know your doctor will need to see you on a regular basis while you are using Norgestimate-ethinyl estradiol tablets. DON’T miss any appointments.
DO know you may have breakthrough bleeding, especially during the first 3 months. DO tell your doctor if this bleeding continues or is very heavy.
DO store Norgestimate-ethinyl estradiol tablets at room temperature away from moisture and heat.
Missing a dose
Missing a pill increases your risk of becoming pregnant.
If you miss one “active” pill:
•DO take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two “active” pills in a row in week one or two:
•DO take two pills per day for two days in a row.
•Then take one pill per day for the rest of the pack. Use back-up birth control for at least seven days following the missed pills.
If you miss two “active” pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks:
•Throw out the rest of the pack and start a new one the same day if you are a Day 1 starter.
•If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss three “active” pills in a row during any of the first 3 weeks:
•Throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter.
•If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.
If you miss two or more pills, you may not have a period during the month.
If you miss a period for two months in a row, call your doctor because you might be pregnant.
If you miss any reminder pills:
•Throw them away and keep taking one pill per day until the pack is empty.
•You don’t need back-up birth control if you miss a reminder pill.
Overdose
Nausea, vomiting and vaginal bleeding are symptoms of overdose. Seek emergency medical attention if you think you have used too much of this medicine.
Things to avoid when taking norgestimate-ethinyl estradiol tablets:
DON’T smoke, especially if you are older than 35. Smoking can further increase your risk of blood clots, stroke or heart attack caused by birth control pills.
DO know that norgestimate-ethinyl estradiol tablets will not protect you from sexually transmitted diseases — including HIV and AIDS. DO use a condom to protect yourself from these diseases.
Norgestimate-ethinyl estradiol tablet side effects
Like all drugs, norgestimate-ethinyl estradiol tablets triggers allergic reactions in some people. Signs of an allergic reaction are hives, difficulty breathing, and swelling of your face, lips, tongue, or throat. Get emergency medical help if you have any of these symptoms.
Stop using norgestimate-ethinyl estradiol tablets and call your doctor at once if you have any of these serious side effects:
•sudden numbness or weakness, especially on one side of the body
•chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling
•swelling in your hands, ankles, or feet
•sudden headache, confusion, problems with vision, speech, or balance
•a change in the pattern or severity of migraine headaches
•nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
•symptoms of depression (sleep problems, weakness, mood changes)
Less serious side effects may include:
•increased hair growth, loss of scalp hair
•changes in weight or appetite
•vaginal itching or discharge
•changes in your menstrual periods
•freckles or darkening of facial skin
•headache, nervousness, dizziness, tired feeling
•breast pain, tenderness, or swelling
•mild nausea, vomiting, bloating, stomach cramps
•problems with contact lenses
Drug interactions
DO know that some drugs can make norgestimate-ethinyl estradiol tablets less effective, which may result in pregnancy. Before using Norgestimate-ethinyl estradiol tablets, do tell your doctor if you are using any of the following drugs:
•phenylbutazone (Azolid, Butazolidin);
•St. John’s wort;
•an antibiotic;
•seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
•a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
•HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.
DO know that this list isn’t complete and there may be other drugs that can affect norgestimate-ethinyl estradiol tablets.
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