SLAYBACK PHARMA: Announces FDA approval of Merzee, generic equivalent of Taytulla® with a Competitive Generic Therapy (CGT) Designation

Slayback Pharma LLC issued the following announcement on Dec. 18.

Slayback Pharma LLC announced today that it has received final approval for its Abbreviated New Drug Application (ANDA) for Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg from the USFDA with a Competitive Generic Therapy Designation.  Merzee is an AB-rated generic equivalent of Taytulla®. Slayback is the "first approved applicant" for such CGT, and is therefore eligible for 180 days of CGT exclusivity. The exclusivity will begin from the date of the first commercial launch of Merzee. Slayback will kick off a full commercial launch under its own label very soon.

Speaking on the approval of Merzee, Ajay Singh, CEO of Slayback Pharma, said, "Approval of our ANDA in less than eight months from filing is a big milestone in our pursuit of excellence in R&D execution. Slayback continues to expand its portfolio and is committed to bringing high quality and affordable generics to the US market."

Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg will soon be available through your wholesaler/distributor.  Please contact our customer service team at 1-844-566-2505.

See the following important safety information and refer to the package insert for full prescribing information.

What is Merzee Used for?
MERZEE is an estrogen/progestin combination oral contraceptive (COC) indicated for use by women to prevent pregnancy.  One capsule is taken daily in order as provided in the blister pack. The efficacy of MERZEE in women who are obese (mass index (BMI) of > 35 kg/m2) has not been evaluated (1).

Important Safety Information for Merzee

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See Full Prescribing Information for complete boxed warning.
• Women over 35 years old who smoke should not use MERZEE.
• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

Do not use Merzee if you:

• have had blood clots, a heart attack or stroke, uncontrolled high blood pressure
• have liver tumors or liver disease 
• have unexplained vaginal bleeding
• are pregnant
• have had breast cancer or other estrogen- or progestin-sensitive cancer 
• are taking Hepatitis C drugs containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir
• Allergic to any of the ingredients in Merzee

Stop using and discuss with your doctor before restarting:

• if a blood clotting occurs or an unexplained change or loss of vision occurs.
• at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, or if you are breastfeeding.
• if you develop liver disease or yellowing of the shin or eyes occurs.
• If you have a history of or develop problems with your gallbladder
• If you are prediabetic or diabetic and should be monitored by your doctor
• have uncontrolled carbohydrate and lipid (fat) metabolic effects, discuss an alternative method of birth control with your doctor.
• if you have significant changes in headaches.
• If you have unusual or absent vaginal bleeding

Possible side effects
The most serious adverse events or side effects which could be life-threatening or lead to permanent disability are:

• cardiovascular events such as heart attack and stroke
• vascular problems such as clotting in lungs and deep veins
• liver disease

The most common adverse reactions reported are:

• irregular vaginal bleeding
• nausea
• breast tenderness
• headache

Merzee may cause decreased milk production in breastfeeding women.

In clinical trials the most common reported side effects were: headache, vaginal infections, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

Drug Interactions
Drugs like Merzee have seriously decreased the effects of thyroid hormone replacement drugs and lamotrigine. Do not take Merzee with hepatitis drugs containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir.

Drugs or herbal products that trigger certain enzymes, including CYP3A4, may decrease the effectiveness of drugs like Merzee or increase breakthrough bleeding. Patients should use a back-up method or alternative method of contraception when these products are used with Merzee and other COCs.

You may report an adverse event related to Merzee made by Slayback Pharma by calling 1-844-566-2505 or emailing medical@slayback-pharma.com.  If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

Original source can be found here.