New Generic Clindamycin Phosphate Gel Granted FDA Approval

Clindamycin phosphate gel is indicated for the treatment of acne vulgaris.

Officials with the FDA have approved Glenmark Pharmaceuticals Limited’s Clindamycin Phosphate Gel USP, 1%, a generic version of Pharmacia & Upjohn’s Cleocin T Gel, 1%.1

According to Pfizer, parent company of Pharmacia & Upjohn, clindamycin phosphate gel is indicated for the treatment of acne vulgaris. In patients ages 12 year and younger, the safety and efficacy of clindamycin phosphate gel has not been established.2

In clinical studies, reported adverse events (AEs) included burning, itching, dryness, erythema, oiliness, and peeling. Additionally, abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have been reported in association with the use of topical formulations of clindamycin.2

Although cases of diarrhea, bloody diarrhea and colitis have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin, these AEs have been rarely reported with topical clindamycin.2

According to IQVIA sales data for the 12 month period ending December 2020, obtained by Glenmark, the market for clindamycin phosphate gel USP, 1% achieved annual sales of approximately $73.8 million.1

REFERENCES

  • Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Gel USP, 1% [news release]. Mumbai, India; February 11, 2021: Glenmark. [email]
  • Cleocin T [prescribing information]. New York, NY; Pharmacia & Upjohn: 2019.