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Research Excerpts

Drugs approved by Usfda in 2016

Year : 2017 | Volume : 5 | Issue : 1

K Parushuram naik1, V Sai lakshmi2, J Jyothirmai3

1,2Assistant Professor, 3Professor, Department of Pharmacology, Prathima Institute of Medical Sciences, Nagunur, Karimnagar, Telangana, India.

Address for correspondence: Dr. K. Parushuram Naik, Assistant Professor, Department of Pharmacology, Prathima Institute of Medical Sciences, Nagunur, Karimnagar, Telangana, India.

Email: kprnaik2k10@gmail.com

Abstract

S.No

Drug Name

Active ingredient

Indication

Dose

Route of administration.

1

Zepatier

Elbasvir and Grazopravir.¹

Chronic Hepatitis C genotypes 1 or 4 infection in adult.

One tablet once daily for 12 Wks (50 mg elbasvir and 100 mg grazoprevir).

Oral.

2

Briviact

Brivaracetam.²

Adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.

 

25-50mg twice daily.

Oral and Intravenous

3

Anthim

Obiltoxaximab.³

Inhalational anthrax due to B. anthracis.

Adult Patients: 16 mg/kg. Pediatric Patients:
Greater than 40 kg: 16 mg/kg,
Greater than 15 kg to 40 kg: 24 mg/kg,
Less than or equal to 15 kg: 32 mg/kg

Intravenous

4

 

 

Taltz

Ixekizumab.4

Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Subcutaneous

5

Cinqair

Reslizumab.5

Severe asthma

3 mg/kg once every 4 weeks by intravenous infusion over 20-50 minutes.

Intravenous

6

Defitelio

Defibrotide sodium.6

Adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

6.25 mg/kg every 6 hours given as a 2-hour IV infusion,
for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution

Intravenous

7

Venclexta

Venetoclax.7

Chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

20 mg once daily for 7 days, followed by a weekly ramp-up dosing schedule to the recommended daily dose of 400 mg.

Oral

8

Nuplazid

Pimavanserin.8

Hallucinations and delusions associated with Parkinson’s disease psychosis.

34 mg, taken orally as two 17 mg tablets once daily, without titration.

Oral

9

Tecentriq

Atezolizumab. 9

Locally advanced or metastatic urothelial carcinoma.

1200 mg as an IV infusion over 60 minutes every 3 weeks.

Intravenous

10

Zinbryta

Daclizumab.10

Multiple sclerosis.

150 milligrams once monthly.

Subcutaneous

11

Ocaliva

Obeticholic acid.¹¹

Chronic liver disease.

 5 mg orally once daily in adults.

Oral

12

Axumin

Fluciclovine F 18.¹²

 A new diagnostic imaging agent to detect recurrent prostate cancer.

370 MBq (10 mCi) as a bolus intravenous injection.

Intravenous

13

Netspot

Gallium Ga 68 dotatate.¹³

A diagnostic imaging agent to detect rare neuroendocrine tumors.

2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi) administered as IV bolus injection.

Intravenous

14

Epclusa

Sofosbuvir and velpatasvir.14

To treat all six major forms of Hepatitis C virus.

One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken once daily.

   Oral

15

Xiidra

Lifitegrast ophthalmic solution.15

To treat the signs and symptoms of dry eye disease.

One drop twice daily in each eye.

Topical.
EYE.

16

Adlyxin

Lixisenatide.16

To improve glycemic control in adults with Type 2 diabetes mellitus.

Initiate at 10 mcg once daily within one hour before the first meal of the day for 14 days. On Day 15, increase dosage to 20 mcg once daily.

Subcutaneous

17

Exondys 51

Eteplirsen17.

Duchenne muscular dystrophy.

30 milligrams per Kg of body weight once weekly, infusion over 35 to 60 minutes.

Intravenous

18

Lartruvo

Olaratumab18.

Soft tissue sarcoma.

15 mg/kg as an infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.

Intravenous

19

Zinplava

Bezlotoxumab19.

To reduce the recurrence of Clostridium difficile infection in patients aged 18 years or older.

Single dose of 10 mg/kg administered as an infusion over 60 minutes.

Intravenous

REFERENCES

1. https://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf

2. https://www.briviact.com/briviact-PI.pdf

3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf

4. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf

5. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf

6. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf

7. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf

8. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf

9. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034s000lbl.pdf

10. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf

11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207999s000lbl.pdf

12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf

13. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf

14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf

15. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208073s000lbl.pdf

16. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf

17. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206488lbl.pdf

18. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf

19. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf

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