FDA Approves New Generic Tadalafil Tablets

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.