SAFETY PULSE VOL. 1

Posted January 15, 2018
SafetyPulse

When you are challenged with the task of identifying a short list of brand name candidates for a new compound, how soon should you start your brand name search and the associated research? How do you start this process? What is the earliest time a sponsor can submit a brand name for review? How long does the brand name review period last? Our newsletter, Safety Pulse, answers these and many other questions in areas such as marketing, regulatory requirements and trademark initiatives.

If you have a general question regarding the brand or generic name of a product OR a specific question regarding the proposed proprietary or nonproprietary name for your asset, please send it to info@safemarkconsulting.com.

NEW APPROVALS FAQ’S

In this issue, we wanted to take a retrospective look at 2017 new approvals.

Q: Any interesting new modifiers approved by the FDA in 2017?

A: Yes. ABILIFY MYCITE was approved for aripiprazole tablet with a sensor.

Q: Is there new product approved that has cocaine as the active ingredient?

A: Yes. The product is called GOPRELTO (cocaine HCL nasal solution, 4%) indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.

Q: Any new approvals with similar naming strategies among related products?

A: Yes. The theme of “DAY” for “once daily” dosing was seen in 2006 with DAYTRANA (methylphenidate transdermal system) and in 2017 with MYDAYIS (mixed salts of a single-entity amphetamine-containing product) extended-release capsules both indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

HEALTHCARE FOCUS APPROVALS

There were a few new approvals (or tentative approva ls)in 2017 intended for treatment of diabetes mellitus:

  • ADMELOG (Insulin Lispro)
  • FIASP (Insulin Aspart Recombinant)
  • FIASP FLEXTOUCH (Insulin Aspart Recombinant)
  • LUSDUNA (Insulin Glargine)

There were 2 new products approved with active ingredients used during the cough, cold, and allergy season:•

  • XHANCE (fluticasone propionate, nasal spray 0.093mg) indicated for nasal polyps in patients 18 years and older.
  • ZERVIATE (cetirizine ophthalmic solution) 0.24% indicated for ocular itching associated with allergic conjunctivitis.

There were new biologics and biosimilar products approved in 2017 using the new 4-letter suffix as part of the proper name to distinguish from other, similar ingredient products:

OGIVRI (trastuzumab-dkst)
• REFLEXIS (infliximab-abda)
• CYLTEZO (adalimumab-adbm)
• HEMLIBRA (emicizumab-kxwh) – new biologic!
• IXIFI (infliximab-qbtx)
• MVASI (bevacizumab-awwb)

DATES TO REMEMBER

European Medicines Agency – Monthly CHMP meetings in 2018 are shown below. Please review EMA website for any updates or changes to the meeting dates posted:

  • 22,23,24,25 Jan 2018
  • 19,20,21,22 Feb 2018
  • 19,20,21,22 Mar 2018
  • 23,24,25,26 April 2018
  • 28,29,30,31 May 2018
  • 25,26,27,28 June 2018
  • 23,24,25,26 July 2018
  • 20,21,22,23 Aug 2018
  • 17,18,19,20 Sept 2018
  • 15,16,17,18 Oct 2018
  • 12,13,14,15 Nov 2018
  • 10,11,12,13 Dec 2018

International NonproprietaryNames (INN)

  • The 66th INN Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances will take place from 1-4 May 2018.
  • Deadline for submissions: New INN requests: Friday 2nd Feb 2018. Please note that “early submissions are encouraged and welcome.”
  • Outstanding INN requests: Friday 26th Jan 2018.
  • Online application is compulsory: https://extranet.who.int/tools/inn_online_

NEW APPROVALS – 2017 CONGRATS!

Although the name approval process can be quite daunting, there are several examples each month of sponsors who successfully have had a name approved with a brand name. We do not have the space to congratulate all the sponsors/manufacturers who have received recent approvals.

However, we would like to point out a few brand names that received approval:

  • ADMELOG
    • Insulin lispro
    • Sanofi-Aventis GmbH
    • Improve glycemic control in adults & pediatric patients 3 years and older with type 1 diabetes mellitus (DM) & adults type 2 DM
  • OGIVRI
    • trastuzumab-dkst
    • Mylan GmbH
    • Oncology. Breast Cancer, Stomach Cancer
  • MAVYRET
    • glecaprevir/pibrentasvir
    • AbbVie, Inc.
    • Antiviral. Chronic Hepatitis C in adults with HCV genotype 1, 2, 3, 4, 5 or 6.
  • SINUVA
    • mometasone furoate, sinus implant
    • Intersect ENT
    • Corticosteroid-eluting sinus implant. Treatment of recurrent nasal polyp disease.

Congratulations to the project teams responsible for this list of New Drug Approvals!

NAME SAFETY REVIEW LESSON

When considering sound-alike and look-alike similarity, is more emphasis placed on the prefix or the suffix part of the word? Although both parts of the word must be considered when evaluating similarity, the PREFIX is more relevant in practice when ordering medications using handwriting, verbal, and eprescribing methods. In addition, the PREFIX helps setthe tone of the word and should be unique in describing a unique product.

MORE NEW APPROVALS

The U.S. Food and Drug Administration today approved LUXTURNA (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. LUXTURNA is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

The FDA approved a new device, REVANESSE ULTRA, a dermal filler that can improve the appearance of facial wrinkles and creases, such as a smile or laugh lines (nasolabial folds). REVANESSE ULTRA is a clear, colorless injectable gel that consists of crosslinked hyaluronic acid (HA) made by Streptococcus bacteria.
Source: fda@go.fda.gov

 

About Brandsymbol

With over two decades of experience, brandsymbol was founded with the goal of revitalizing the agency-client relationship by innovating and transforming the branding process, to deliver world-class solutions, customized for each client. Our proprietary i4 Methodology is engineered to provide senior-level expertise, global creative, advanced legal & regulatory solutions to deliver clients world-class brands that are based on facts and figures, not opinions and observations.

About SafeMark

SafeMark is redefining the safety industry by implementing a new gold standard in name safety testing. Our primary objective is to provide healthcare clients with a simple and sequential approach to name safety testing that adheres to guidelines set forth by global governmental authorities.

For More Information:

Casey Peebles

cpeebles@brandsymbol.com

704.879.2503

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