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 Table of Contents  
WHATS IN NEWS
Year : 2018  |  Volume : 4  |  Issue : 1  |  Page : 45-46

News from regulatory corner: Safety communication and recent drug approvals


Department of Clinical Division, Central Leprosy Teaching and Research Institute, Ministry of Health and Family Welfare, Government of India, Chengalpattu, Tamil Nadu, India

Date of Web Publication10-Jul-2018

Correspondence Address:
Prof. Pugazhenthan Thangaraju
Central Leprosy Teaching and Research Institute, Ministry of Health and Family Welfare, Government of India, Chengalpattu, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdd.ijdd_3_18

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How to cite this article:
Thangaraju P, Venkatesan S. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol 2018;4:45-6

How to cite this URL:
Thangaraju P, Venkatesan S. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol [serial online] 2018 [cited 2018 Dec 11];4:45-6. Available from: http://www.ijdd.in/text.asp?2018/4/1/45/236286

Sir,

The following were the recently approved drug for dermatology by the USFDA.


  Ilumya (Tildrakizumab-Asmn) Top


March 21, 2018

The US Food and Drug Administration (FDA) has approved Ilumya, an interleukin-23 antagonist that is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for the treatment involving systemic or phototherapy. It is a solution for subcutaneous injection, and the recommended dose is 100 mg at weeks 0, 4, and every 12 weeks thereafter.

Source: https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100253/ilumya-tildrakizumab-asmn


  XEPI (Ozenoxacin) Cream, for Topical Use in Impetigo Top


November 12, 2017

The USFDA has approved XEPI a quinolone antibiotic for the topical treatment of impetigo that was caused by strains Staphylococcus aureus or Streptococcus pyogenes in adult as well as in pediatric patients 2 months of age and older. This should be applied as a thin layer of XEPI topically to the affected area twice daily for 5 days.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208945lbl.pdf


  Eskata (Hydrogen Peroxide) Topical Solution for Seborrheic Keratoses Top


December 14, 2017

The USFDA has approved high-concentration of 40% hydrogen peroxide-based topical solution for seborrheic keratoses. Eskata should be applied to seborrheic keratosis lesions 4 times with an interval of 1 min apart. The unit dose applicator should be discarded after it is used.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209305s000lbl.pdf

This section emphasized on the regulatory action regarding adverse drug action. Here, the names of drugs with their adverse effect were given.


  PvPI Recommendations to CDSCO for Regulatory Actions Top


November 13, 2017

Around 19 drugs were known to cause adverse drug reaction where the symptoms involved skin and related structures. The antiepileptic drugs, namely carbamazepine, lamotrigine caused  Stevens-Johnson syndrome More Details (SJS) and Toxic Epidermal Necrolysis (TEN); phenytoin caused Acute Generalized Exanthematous Pustulosis (AGEP). Among vaccines anti-rabies vaccine was found to cause Erythema Multiforme. Among antibiotics, ceftriaxone caused SJS; azithromycin, cloxacillin, cefixime caused AGEP; amoxicillin/clavulanate, potassium and ciprofloxacin caused SJS and TEN. The steroid betamethasone, and antifungal itraconazole were found to cause photosensitivity reactions Ibuprofen and sulfasalazine, caused SJS and TEN. Among diuretics, furosemide caused lichenoid dermatitis. Antifungal fluconazole caused hyperpigmentation and terbinafine caused AGEP.

Source: http://www.ipc.gov.in/PvPI/das/PvPI%20recommendations%20to%20CDSCO%20for%20regulatory%20actions%20.pdf


  Health Ministry Bans Over-The-Counter Sale of 14 Steroid Creams Top


April 8, 2018.

The government of India has banned over the counter (OTC) sale of 14 dermatological creams and ointments containing steroids as main substances. A sustained campaign was made by dermatologists across the country. They called for an exclusive ban on manufacture and sale of steroid- based topical preparations like ointments and insisted for its ban by the Ministry of Health and Family Welfare. The government has proposed amendments to the Drugs and Cosmetic Rules, 1945 inserting potent corticosteroid ingredients in Schedule H that would restrict the OTC sale of the topical creams. The drugs containing the potent corticosteroids include Alclometasone, Beclomethasone, Betamethasone, Desonide, Desoximetasone, Diflorasone Diacetate, Fluocinonide, Fluocinolone acetonide, Halobetasol Propionate, Halometasone, Methylprednisone, Prednicarbate, and Triamcinolone Acetonide.

Sources: http://www.newindianexpress.com/nation/2018/apr/08/health-ministry-bans-over-the-counter-sale-of-14-steroid-creams-1798739.html

https://www.livemint.com/Industry/c6v4JwnveXqtRwZiBqXX6I/Govt-plans-ban-on-sale-of-fairness-creams-with-steroids.html

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.




 

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Ilumya (Tildraki...
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