8/19/22, 11:20 AM
`
`Slayback Pharma announces FDA approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 mL in a multi-dose via…
`
`Slayback Pharma announces FDA
`approval of Hydroxyprogesterone
`Caproate Injection, USP 1,250 mg/ 5
`mL in a multi-dose vial, the rst
`generic equivalent of Makena®
`Injection 1,250 mg/ 5 mL multi-dose
`vial
`
`NEWS PROVIDED BY
`Slayback Pharma LLC
`
`Jan 02, 2019, 08:00 ET
`
`PRINCETON, N.J., Jan. 2, 2019 /PRNewswire/ -- Slayback Pharma LLC announced today that the
`U.S. Food and Drug Administration ("FDA") granted approval of its abbreviated new drug
`application ("ANDA") for Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml.  This is
`the rst and only ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a
`multi-dose vial.  Slayback will commence the commercial launch of this product under its own
`label shortly.
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-fda-approval-of-hydroxyprogesterone-caproate-injection-usp-1-250-mg-5-ml… 1/4
`
`
`
`Eye Therapies Exhibit 2126, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/19/22, 11:20 AM
`Slayback Pharma announces FDA approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 mL in a multi-dose via…
`Ajay Singh, CEO of Slayback Pharma, said: "Slayback's journey has had a singular focus - to
`develop specialty products, including generics, that are complex; otherwise difcult to develop
`and/or present other barriers to entry.  For many such products, affordable generic options do
`not exist today because of the inherent technical barriers to entry.  Today's approval is a
`signicant milestone in our journey.  We are thrilled and honored to have the opportunity to
`launch the rst approved ANDA for such an important product.  Slayback is looking forward to
`a series of approvals for generics that are difcult to develop or provide barriers to entry."
`
`Slayback Pharma's Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml was
`determined by the FDA to be therapeutically equivalent to Makena (Hydroxyprogesterone
`® 
`Caproate 1,250 mg/ 5 ml) sold in the United States by AMAG Pharmaceuticals, Inc. 
`Hydroxyprogesterone Caproate Injection, USP is available in a 250 mg/ ml, 5 ml multi-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 benet, such as improvement in neonatal mortality and morbidity.
`
`Limitation of use: While there are many risk factors for preterm birth, safety and efcacy 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)
`
`
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-fda-approval-of-hydroxyprogesterone-caproate-injection-usp-1-250-mg-5-ml… 2/4
`
`Eye Therapies Exhibit 2126, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/19/22, 11:20 AM
`Slayback Pharma announces FDA approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 mL in a multi-dose via…
`HPC should not be used in women who have or have had any of the following conditions:
`
`blood clots or blood clotting problems,
`breast cancer, suspected breast cancer or other hormone-sensitive cancers, or history of
`these conditions;
`unusual vaginal bleeding not related to your current pregnancy,
`yellowing of the skin due to liver problems during pregnancy,
`liver problems, including liver tumors,
`uncontrolled high blood pressure.
`
`Before you take HPC, tell your healthcare provider about all your medical conditions, including
`if you have:
`
`an allergy to HPC, castor oil, or any of the other ingredients in HPC;
`diabetes or prediabetes,
`problems retaining water such as epilepsy, migraine headaches, asthma, heart or kidney
`problems,
`depression,
`yellowing of the skin or whites of your eyes,
`or high blood pressure.
`
`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 uid levels).
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-fda-approval-of-hydroxyprogesterone-caproate-injection-usp-1-250-mg-5-ml… 3/4
`
`
`
`Eye Therapies Exhibit 2126, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`8/19/22, 11:20 AM
`Slayback Pharma announces FDA approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 mL in a multi-dose via…
`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, 11/2018.
`
`Makena® is a registered trademark of AMAG Pharmaceuticals, Inc.
`
`SOURCE Slayback Pharma LLC
`
`Related Links
`http://www.slayback-pharma.com
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-fda-approval-of-hydroxyprogesterone-caproate-injection-usp-1-250-mg-5-ml… 4/4
`
`
`
`Eye Therapies Exhibit 2126, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`