Le Lézard
Classified in: Health
Subject: FDA

Slayback Pharma announces approval of Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 mL in a single-dose vial, generic equivalent of MakenaŽ Injection 250 mg/ 1 mL


PRINCETON, N.J., March 25, 2019 /PRNewswire/ -- Slayback Pharma LLC announced today that it has received final approval for Hydroxyprogesterone Caproate Injection, USP 250 mg/ 1 ml.  This is the second ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a preservative-free single-dose vial that is therapeutically equivalent to Makena.  

(PRNewsfoto/Slayback Pharma LLC)

Ajay Singh, CEO of Slayback Pharma, said: "Today's approval is yet another significant milestone in our quest of improving access to generic medicines with technical barriers to entry. FDA had recently announced[1] that Makena single-dose 1ml vial as well as the multi-dose 5 ml vials are listed as a drug shortage.  Slayback's approval comes at an appropriate time as it will facilitate access to this important product.  Slayback has sufficient stock ready to enable a commercial launch immediately."

Hydroxyprogesterone Caproate Injection, USP is available in a 250 mg/ ml, 1 ml single-dose vial and can be ordered 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.

Indication

Hydroxyprogesterone caproate (HPC) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.  The effectiveness of HPC is based on improvement in the proportion of women who delivered <37 weeks of gestation.  There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of HPC has been demonstrated only in women with a prior spontaneous singleton preterm birth.  It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Important Safety Information for Hydroxyprogesterone Caproate Injection (HPC)

HPC should not be used in women who have or have had any of the following conditions:

Before you take HPC, tell your healthcare provider about all your medical conditions, including if you have:

If any of these medical conditions occur while you are taking HPC, check with your doctor to see if you should continue using it.

Possible side effects: In a clinical study, some complications or new medical conditions associated with pregnancy occurred more often in women who received HPC.  These included miscarriage (pregnancy loss), stillbirth (fetal death), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes (diabetes occurring during pregnancy), and oligohydramnios (low amniotic fluid levels).

Two serious side effects were reported in study patients: one developed a pulmonary embolus (blood clot in her lung), and the other developed cellulitis (injection site infection of the skin).  HPC may also cause other serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes.

The most common side effects of HPC include hives, itching, nausea, and diarrhea, and injection site reactions (pain, swelling, itching, and development of a hard lump).

You may report an adverse event related to Hydroxyprogesterone Caproate 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.

Please see full Prescribing Information for Hydroxyprogesterone Caproate Injection (HPC).        

References:
Hydroxyprogesterone Caproate Injection prescribing information. Slayback Pharma, 1/2019.

MakenaŽ is a registered trademark of AMAG Pharmaceuticals, Inc.

__________________
[1] March 12, 2019 https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydroxyprogesterone%20Caproate%20Injection&st=c&tab=tabs-1

SOURCE Slayback Pharma LLC


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News published on 25 march 2019 at 09:33 and distributed by: