FDA Approves New Generic Tadalafil Tablets

December 31st 2020
Contemporary Clinic Staff

This drug product is a new generic equivalent to Eli Lilly’s Cialis Tablets, indicated for erectile dysfunction and the treatment of benign prostatic hyperplasia.

Officials with the FDA have approved Glenmark Pharmaceuticals’ Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg.1

This drug product is a new generic equivalent to Eli Lilly’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg,1 which is indicated for erectile dysfunction and the treatment of benign prostatic hyperplasia.2

The most common adverse reactions (≥ 2%) for tadalafil are headache, flushing, dyspepsia, nasal congestion, back pain, myalgia, and pain in limb.2

Sales data for the 12 month period ending November 2020, the Cialis Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg market achieved annual sales of approximately $125.5 million.1


REFERENCES

  1. Glenmark Pharmaceuticals receives ANDA final approval for Tadalafil Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg; and receives ANDA tentative approvals for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg and Apremilast Tablets, 10 mg, 20 mg and 30 mg [news release]. Mumbai, India; December 31, 2020: Glenmark Pharmaceuticals. [email].
  2. Cialis [prescribing information]. Indianapolis, IN; Eli Lilly & Company; 2018.

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