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 Table of Contents  
Year : 2015  |  Volume : 1  |  Issue : 1  |  Page : 57-58

Recent drug approvals in dermatology

Date of Web Publication1-Dec-2015

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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/WKMP-0110.170766

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How to cite this article:
. Recent drug approvals in dermatology. Indian J Drugs Dermatol 2015;1:57-8

How to cite this URL:
. Recent drug approvals in dermatology. Indian J Drugs Dermatol [serial online] 2015 [cited 2023 Jun 1];1:57-8. Available from: https://www.ijdd.in/text.asp?2015/1/1/57/170766

As a dermatologist who is dealing with many drugs in clinical practice, it is imperative for him/her to be updated with recent approvals by regulatory authorities such as Unites States Food and Drug Administration (US-FDA) and Indian Regulatory authority i.e., Drug Controller General of India. Knowledge about drug approvals or drug ban helps dermatologist to make more informed decisions regarding treatment modalities. These are some of the important and recent developments in the last 2 years related to dermatology.

  2014 Top

Sivextro™ (tedizolid): June 2014, approved for acute bacterial skin and skin structure infections

Sivextro™ (tedizolid) belongs to oxazolidinone (linezolid) group of antibiotics. It acts by inhibition of 50 s subunit of RNA causing inhibition of protein synthesis. It has shown to have action against Gram-positive bacteria such as Staphylococcus aureus (including methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus inosus, Streptococcus intermedius, Streptococcus constellatus, and Enterococcus faecalis). It is available as both oral and intravenous (IV) infusion. Recommended dose is 200 mg administered once daily for 6 days either as orally or as IV infusion.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402174.htm.

Not available in India (current international price: 2000 USD for six tablets approximately).

Jublia™ (efinaconazole) 10% topical gel: June 2014, approved for onychomycosis for toe nails

Jublia™ (efinaconazole) is an azole antifungal that has been approved for topical treatment of toe nail onychomycosis caused by Trichophyton rubrum and Trichophyton mentagrophytes. It acts by inhibiting ergosterol synthesis. Advised application is once daily for 48 weeks.

Link: http://www.fda.gov/drugs/informationondrugs/ucm422419.htm.

Not available in India (current international price: 450 USD per 4 ml bottle approximately).

Kerydin™ (tavaborole): July 2014, approved for onychomycosis of the toe nails

Kerydin™ (tavaborole) is an oxaborole antifungal. It has been approved for toe nail onychomycosis due to T. rubrum and T. mentagrophytes. It is available as a 5% solution for topical application over the affected toe nail surface, once daily for 48 weeks. It acts by inhibiting fungal aminoacyl transfer ribonucleic acid synthase.

Link: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. DrugDetails.

Not available in India (current international price: 1250 USD per bottle approximately).

Orbactiv™ (oritavancin): August 2014, approved for acute bacterial skin and skin structure infection

Orbactiv™ (oritavancin) is a semisynthetic lipoglycopeptide antibacterial drug. It is active against Gram-positive bacteria such as S. aureus (including methicillin-resistant isolates), S. pyogenes, S. agalactiae, Streptococcus dysgalactiae, and E. faecalis (vancomycin-susceptible isolates only). It is available as IV infusion. Recommended dose is a 1200 mg IV infusion over 3 h, single dose. It acts by inhibiting bacterial cell wall synthesis.

Link: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm408475.htm.

Not available in India (current international price: 1000 USD per infusion approximately).

  2015 Top

Cosentyx™ (secukinumab) injection: January 21, 2015, approved for moderate-to-severe plaque psoriasis

Cosentyx™ (secukinumab) is a monoclonal antibody approved for the treatment of moderate to severe chronic plaque psoriasis. It selectively binds to interleukin-17A and prevents its binding to its receptor thereby preventing activation of inflammatory response. It is given as a subcutaneous injection.

Link: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm430969.htm.

Not available in India (current international price: 8000 USD per injection approximately)

Kybella (deoxycholic acid): April 29, 2015, approved for moderate-to-severe submental fat

The US-FDA has approved Kybella (deoxycholic acid), as treatment for adults for lysis of moderate-to-severe fat below the chin, known as submental fat (double chin). Using Kybella for the treatment of fat outside of the submental area is not yet approved. Deoxycholic acid is used as a constituent in mesotherapy cocktails in Mesolipolysis. Deoxycholic acid is a cytolytic drug, which when injected into tissue physically destroys the cell membrane causing lysis. Kybella is administered as an injection into the fat tissue in the submental area.

Finacea (azelaic acid) Foam: July 31, 2015, approved for papulopustular rosacea

US-FDA has approved Finacea (azelaic acid) Foam, 15% for the topical treatment of mild to moderate rosacea comprising inflammatory papules and pustules.

(This is compiled by editorial team for the purpose of information only and content may change or may have changed until the time of publishing).


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