Every New FDA Drug Approval in 2017

January 9, 2018

The last 12 drugs approved in the year, along with the other 34.

2017 was a busy year for the FDA. With 46 approvals, the year far outpaced the 22 approvals in 2016.

We’ve already shown you everyothernewdrug approval in 2017, but these are the latest 12 approved in 2017. From treating cancers to hemophilia to Sly syndrome to multiple diabetes treatments, the latest approvals cover a wide variety of diseases and patients.

Click through to see the latest FDA approvals

 

CALQUENCE (acalabrutinib), AstraZeneca

Indications: A kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Dosage: 100 mg orally approximately every 12 hours, with or without food. Advise patients not to break, open, or chew capsules. Manage toxicities using treatment interruption, dose reduction, or discontinuation.

Contraindications: None.

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VYZULTA (latanoprostene bunod ophthalmic solution), Bausch + Lomb

Indications: A prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage: One drop in the affected eye(s) once daily in the evening.

Contraindications: None

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PREVYMIS (letermovir), Merck

Indications: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Dosage: 480 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant. If PREVYMIS is coadministered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.

Contraindications: Pimozide, Ergot alkaloids, and pitavastatin and simvastatin when co-administered with cyclosporine.

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Fasenra (benralizumab), AstraZeneca

Indications: Add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Dosage: By subcutaneous injection, 30 mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter.

Contraindications: Known hypersensitivity to benralizumab or excipients.

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MEPSEVII (vestronidase alfa-vjbk), Ultragenyx Pharmaceutical

Indications: the treatment of mucopolysaccharidosis VII (MPS VII, also known as Sly syndrome).

Dosage: 4 mg/kg administered every two weeks as an intravenous infusion.

Contraindications: None

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Hemlibra (emicizumab-kxwh), Genentech

Indications: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

Dosage: 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly.

Contraindications: None

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Click here to read the full label

 

 

OZEMPIC (semaglutide), Novo Nordisk

Indications: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage: Subcutaneous injection. Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly.

Contraindications: Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to OZEMPIC or any of the product components.

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Xepi (ozenoxacin), Medimetriks Pharmaceuticals

Indications: The topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.

Dosage: Apply a thin layer of XEPI topically to the affected area twice daily for 5 days.

Contraindications: None.

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RHOPRESSA (netarsudil ophthalmic solution), Aerie Pharmaceuticals

Indications: The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage: One drop into the affected eye(s) once daily in the evening.

Contraindications: None

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STEGLATRO (ertugliflozin), Merck and Pfizer

Indications: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage: Starting dose is 5 mg once daily, increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control.

Contraindications: Severe renal impairment, end-stage renal disease, or dialysis. History of serious hypersensitivity reaction to STEGLATRO.

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Macrilen (macimorelin), Aeterna Zentaris

Indications: The diagnosis of adult growth hormone deficiency.

Dosage: 0.5 mg/kg as a single oral dose, after fasting for at least 8 hours.

Contraindications: None

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GIAPREZA (angiotensin II), La Jolla

Indications: Increase blood pressure in adults with septic or other distributive shock.

Dosage: Start intravenously at 20 nanograms (ng)/kg/min. Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min.

Contraindications: None

Click here to read the full label