Slayback Pharma announces FDA approval of Merzee, generic equivalent of Taytulla with a Competitive Generic Therapy (CGT) Designation
PRINCETON, N.J., Dec. 18, 2020 /PRNewswire/ -- 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 RandD 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:
Stop using and discuss with your doctor before restarting:
Possible side effectsThe most serious adverse events or side effects which could be life-threatening or lead to permanent disability are:
The most common adverse reactions reported are:
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 InteractionsDrugs 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 [email protected]. 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.
References:Merzee full Prescribing Information (1) Slayback Pharma, 12/2020Taytulla® is a registered trademark of Allergan Pharmaceuticals International Limited
SOURCE Slayback Pharma LLC
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