Accord Healthcare US Relaunches Tadalafil Tablets, Broadening Availability of Approved Dosage Strengths

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May 04, 2026, 08:05 ET

RALEIGH, N.C., May 4, 2026 /PRNewswire/ -- Accord Healthcare, Inc., a leading generic pharmaceutical company, committed to improving access to affordable medicines, today announced the relaunch of Tadalafil Tablets, an FDA-approved phosphodiesterase type 5 (PDE5) inhibitor for oral administration, available in multiple dosage strengths.

Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and the combination of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED/BPH).

"The relaunch of Tadalafil Tablets reflects Accord Healthcare's continued commitment to maintaining access to established, FDA‑approved medicines across approved indications," said Nuvan Dassanaike, Senior Vice President, Digital & Marketing Operations.

Tadalafil Tablets are available in four strengths: 2.5 mg, 5 mg, 10 mg, and 20 mg, providing doctors with multiple prescribing options in accordance with the approved Prescribing Information.

Further information about safety and potential side effects can be found in the Prescribing Information.

For more information, please visit the Products page at Accord Healthcare US.

Important Safety Information

You should not take Tadalafil Tablets if you are using any form of organic nitrates, guanylate cyclase (GC) stimulators such as riociguat, or if you have a known serious hypersensitivity to tadalafil or ADCIRCA®.

Tadalafil Tablets can cause serious side effects including:

Sudden vision loss. Stop taking Tadalafil Tablets and seek medical attention immediately if you experience a sudden loss of vision in one or both eyes. This may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can cause permanent vision loss. Use with caution in patients with a history of NAION or a "crowded" optic disc.
Sudden hearing loss. Stop taking Tadalafil Tablets and seek prompt medical attention if you experience a sudden decrease or loss of hearing, which may be accompanied by ringing in the ears or dizziness.
Prolonged erection. Erections lasting greater than 4 hours, whether painful or not, require emergency medical attention. Priapism, if not treated promptly, can result in irreversible damage to erectile tissue. Use with caution in patients predisposed to priapism, such as those with sickle cell anemia, multiple myeloma, or leukemia.
Serious drop in blood pressure. Taking Tadalafil Tablets with nitrates, alpha-blockers, antihypertensive medications, or substantial amounts of alcohol (5 or more units) may lead to a significant drop in blood pressure, causing dizziness, fainting, or other serious cardiovascular events.
Cardiovascular risk. Tadalafil Tablets should not be used in men for whom sexual activity is inadvisable due to their underlying cardiovascular status. Patients who experience chest pain, dizziness, or nausea during sexual activity should stop and seek immediate medical attention.

The most common side effects of Tadalafil Tablets, reported in at least 2% of patients, include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb. Back pain and myalgia generally occur 12 to 24 hours after dosing and typically resolve within 48 hours. These are not all the possible side effects of Tadalafil Tablets. For more information, ask your doctor or pharmacist.

Tadalafil Tablets are not indicated for use in females or pediatric patients. In patients with severe hepatic impairment (Child-Pugh Class C) or creatinine clearance less than 30 mL/min on once-daily dosing, use is not recommended. Dose adjustments are required in patients with renal or hepatic impairment; talk to your healthcare provider about the appropriate dose for your condition.

About Accord Healthcare US

Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company. Accord Healthcare is committed to improving lives by increasing access to medicines while also providing novel solutions that enhance the pharmaceutical experience for both healthcare providers and patients. Accord Healthcare combines its advanced manufacturing technology with in-house research to produce highly complex, affordable, and essential medicines. Accord Healthcare's forward-thinking, innovative approach, and its resolve to help patients remains at the heart of everything they do. Accord Healthcare is headquartered in Raleigh, North Carolina. The Intas network markets its products in 85 countries. To learn more, visit the Accord Healthcare website.

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