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 Table of Contents  
Year : 2019  |  Volume : 5  |  Issue : 2  |  Page : 121-122

News from regulatory corner: Safety communication and recent drug approvals

Consultant Dermatologist, Bhabha Hospital, Bandra, Mumbai, Maharashtra, India

Date of Web Publication16-Dec-2019

Correspondence Address:
Dr. Manasi Shirolikar
C-1, DAE (BARC) Building, 15th Road, Bandra West, Mumbai - 400 050, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijdd.ijdd_65_19

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How to cite this article:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol 2019;5:121-2

How to cite this URL:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol [serial online] 2019 [cited 2024 Mar 1];5:121-2. Available from: https://www.ijdd.in/text.asp?2019/5/2/121/272967


The following were the recently approved drugs for dermatology by the US Food and Drug Administration (USFDA) and/or European Commission.

  Ranitidine Recalled over Findings of it Containing a Nitrosamine Impurity Called N-Nitrosodimethylamine Top

The USFDA advised companies to recall their ranitidine if testing shows levels of N-nitrosodimethylamine (NDMA) above the acceptable daily intake (96 ng per day or 0.32 parts per million for ranitidine).

The FDA continues to investigate the presence of the NDMA impurity in ranitidine and was made aware of NDMA in nizatidine, which is chemically similar to ranitidine.

Both medicines are H2 blockers which decrease the amount of acid in the stomach. FDA identified NDMA in ranitidine and nizatidine active pharmaceutical ingredient (API) and finished drugs.

The Medicines and Healthcare products Regulatory Agency, United Kingdom, also issued an alert to healthcare professionals, as a few pharma companies are recalling all unexpired stock of certain batches of prescription-only ranitidine medicines used to treat conditions, such as heartburn and stomach ulcers.

The recall is a precautionary measure due to possible contamination with an impurity called NDMA, which has been identified as a risk factor in the development of certain cancers.

Patients were advised not to stop taking their medication and ask to change the drug during the next routine appointment.

The Drug Controller General of India, in a letter, directed state drug regulators to ask pharmaceutical companies to check their products for the carcinogen. It also asked them to ensure that the drug is sold only under prescription. It is a prescription drug included in Schedule H, and therefore, it should be sold by retail only under prescription of a Registered Medical Practitioner. State drug regulators were asked to communicate with the manufacturers of ranitidine API and formulations under their jurisdiction to verify their products and take appropriate measures to ensure patient safety.


  1. https://indianexpress.com/article/business/cdsco-flags-ranitidine-over-possible-presence-of-carcinogenic-impurity-6025750/.
  2. https://www.gov.uk/government/news/ranitidine-oral-solution-and-tablets-recall.
  3. https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine.

  Minocycline Topical Foam (4%) for Inflammatory Lesions of Nonnodular Moderate-To-Severe Acne Vulgaris (Amzeeq, Foamix Pharmaceuticals) Top

The USFDA has approved minocycline topical foam (4%) for inflammatory lesions of nonnodular moderate-to-severe acne vulgaris in adults and children aged 9 years or older.

Minocycline is a broad-spectrum antibiotic known for its efficacy in treating moderate-to-severe acne, but its use is limited in some patients due to systemic side effects when taken orally.

Minocycline has only been available as a systemic formulation due to its instability in traditional topical formulations. However, it has been stabilized by Foamix to effectively deliver minocycline in a foam-based vehicle.

The foam is a once-daily treatment regimen that maintains the stability of the active ingredient while delivering it into the skin.

The FDA approval of AMZEEQ is supported by the data from three Phase 3 clinical trials in 2418 patients of 9 years of age or older, making it one of the largest clinical programs for acne to date. In each 12-week, multicenter, randomized, double-blind, vehicle-controlled study, subjects with moderate-to-severe acne vulgaris were treated once-daily with AMZEEQ or vehicle. No other topical or systemic acne medication was permitted to be used by subjects during the study period. The studies each found statistically significant disease improvement with AMZEEQ versus vehicle for the co-primary endpoint of absolute reduction of inflammatory lesions. The most common adverse reaction was headache, which was reported in 3% of subjects treated with AMZEEQ versus 2% of subjects treated with vehicle.

AMZEEQ is expected to be available for prescribing in January 2020.


  1. https://www.medscape.com/viewarticle/920124.
  2. https://www.foamix.com/news-releases/news-release- details/update-foamix-receives-fda-approval-amzeeqtm -topical-minocycline.

  Cetirizine Injection for Acute Urticaria (Quzyttir, JDP Therapeutics) Top

The USFDA has approved cetirizine hydrochloride for intravenous (IV) injection (Quzyttir, JDP Therapeutics) for the treatment of acute urticaria in adults and children 6 months of age or older.

Cetirizine injection is not recommended in children aged younger than 6 years with impaired renal or hepatic function.

Quzyttir will be available as 10 mg/mL single-use vials.

The approval was based on the results of Phase 3 double-blind, randomized, active-controlled clinical trial involving 262 patients aged 18 or older with acute urticaria. Results showed that cetirizine injection was noninferior to diphenhydramine, based on change from baseline in patient-rated pruritus score. Fewer cetirizine-treated patients than diphenhydramine-treated patients returned to the emergency department or clinic (6% vs. 14%).

Treatment-emergent adverse reactions included dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The recommended dosage regimen for Quzyttir is once every 24 h as needed. Quzyttir should be administered as an IV push over 1–2 min. The recommended dosage is based on age:

  • Adults and adolescents – 12 years of age and older: 10 mg
  • Children – 6–11 years of age: 5 mg or 10 mg depending on symptom severity
  • Children – 6 months to 5 years of age: 2.5 mg.


  1. https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/news/rxnews/drug-approvals/drugapproval_quzyttir_2019-1007.pdf.
  2. https://www.medscape.com/viewarticle/919911.

  Trifarotene Cream (0.005%) for the Topical Treatment of Acne Vulgaris (Aklief, Galderma) Top

The USFDA has approved topical trifarotene (Aklief, Galderma) for the treatment of acne vulgaris in patients 9 years of age and older.

Trifarotene is a topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.

Aklief is supplied as a cream for topical administration, to be applied to the affected areas once daily, in the evening, on clean and dry skin.

The use of a moisturizer is recommended as frequently as needed from the initiation of treatment.

The FDA approval was based on the data from two pivotal Phase 3 clinical trials of once-daily Aklief cream in patients with moderate acne on the face and trunk. The two identical 12-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled clinical trials enrolled 2420 patients. Results showed that Aklief cream significantly reduced inflammatory lesions as early as 2 weeks on the face and 4 weeks on the back, shoulders, and chest compared to vehicle. Aklief cream was well tolerated when used on the face, back, shoulders, and chest.

Adverse effects reported were application site irritation, application site pruritus, and sunburn.


  1. https://www.galderma.com/us/sites/g/files /jcdfhc341/files/2019-10/10-2-2019%20Revised%20PI%20NDA%20211527.pdf.
  2. https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100433/aklief-trifarotene.

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Conflicts of interest

There are no conflicts of interest.


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Ranitidine Recal...
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