HORIZON LINES: A QUARTERLY REVIEW OF NDAs


HORIZON LINES A Quarterly Review of NDAs – 2Q16


Sonal Pathak, MS, Harshada Sant, MS and Hemant N. Joshi, PhD, MBA*


Tara Innovations LLC, *hemantjoshi@tarainnovations.com


This column summarizes New Drug Applications (NDAs) approved in the second quarter 2016 (May-June 2016). In this quarter, FDA approved 23 NDAs.


Sixteen (69.5%) NDAs were for small molecules while the remaining seven molecules (30.5%) were large molecules. The use of large molecules for treatment of diseases such as cancer and HIV has increased recently. In this quarter, thirteen companies (56.5%) receiving NDA approvals were large companies and the remaining ten companies (43.5%) were mid- sized and small companies. Bayer health sciences, Teva pharmaceuticals and Gilead Sciences bagged two NDAs each in this period. Five out of 23 (21.7%) of NDAs were combination dosage forms, out of which Odefsey® had three different drugs. Six out of 23 NDA’s (26.1%) were for treatment of various types of cancers. The types of dosage forms approved were – Tablets and capsules : nine (39.1%), Injections : ten (43.5%), Ophthalmic/ Otic solutions: two (8.7%), Inhalation powder: one (4.3%) and Metered dose inhaler: one (4.3%).


Odefsey® contains emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or E/R/TAF and was approved for the treatment of HIV-1 infection in certain patients. Odefsey® is Gilead’s second TAF- based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV. Gilead also obtained an approval for Descovy® which contains Emtricitabine and tenofovir alafenamide


Approval date (2016)


March 1 March 4 Trade Name Odefsey Idelvåion March 4 Imbruvica March 10 Evomela Drug Name Emtricitabine,


Rilpivirine, and Tenofovir


Coagulation factor IX


(recombinant), albumin fusion protein


Ibrutinib Melphalan Injection Capsule CSL Behring Janssen Pharmaceuticals Inc. Hemophilia B


chronic lymphocytic leukemia


Injection Spectrum Pharmaceuticals, Inc. Multiple Myeloma Pharmaceutical Outsourcing | 44 | November/December 2016 Tablets Gilead Sciences, Inc HIV Infection Dosage Form


Idelvion® is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the US that is modified to last longer in the blood.


Defetelio® is the first FDA-approved therapy for treatment of severe hepatic VOD (Veno-occlusive disease), a rare and life-threatening liver condition.


Inflectra™ is a biosimilar to Janssen Biotech’s Remicade (infliximab), which was originally licensed in 1998.


BromSite™ is the first non-steroidal anti-inflammatory drug (NSAID) approved by the FDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery.


Venclexta™ is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is over-expressed in many patients with CLL (chronic lymphocytic leukemia).


Nuplazid™ (Pimavanserin) tablets are the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.


Flamel obtained NDA approval for Akovaz™ and is the first to receive approval from the FDA for ephedrine sulfate.


Otovel (ciprofloxacin 0.3 % and Fluocinolone Acetonide 0.025 %) otic solution, the first and only antibiotic and steroid combination ear drop available in sterile, preservative-free single-dose vials.


Company Indication Comment


Emtricitabine and tenofovir alafenamide are from Gilead Sciences and Rilpivirine is from Janssen Sciences


First coagulation factor-albumin fusion protein


Approved for First line treatment for CLL


First FDA-approved for the high-dose conditioning indication in MM.


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