Alembic Pharmaceutical Ltd. has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated New Drug Application (ANDA) for generic vardenafil hydrochloride tablets in potencies 2.5 mg, 5 mg, 10 mg, and 20 mg.
Vardenafil is sold under the brand name Levitra, which is developed by Bayer Healthcare Pharmaceuticals, a German multinational pharmaceutical and life sciences company.
The FDA approved ANDA for generic vardenafil is therapeutically bioequivalent to the Levitra tablets in potencies 2.5 mg, 5 mg, 10 mg, and 20 mg by Bayer.
Vardenafil is indicated for the treatment of erectile dysfunction (ED), a male sexual disorder in which men fail to get or sustain an erection hard enough for sexual activity.
Like sildenafil (Viagra) and tadalafil (Cialis), vardenafil belongs to the class of drugs called PDE5 (phosphodiesterase type 5) inhibitors.
The drug helps boost penile blood flow so a man can experience a stronger erection for successful sexual intercourse.
The estimated global vardenafil market size is $35 million for one year, according to IQVIA, an American multinational company serving the combined industries of health information technology and clinical research.
Alembic has a total of 78 ANDA approvals – 65 final approvals and 13 tentative approvals – from the FDA.
Headquartered in Gujarat, India, Alembic is involved in the manufacturing of drugs, pharmaceutical substances, and intermediates.
Alembic is one of the leaders in manufacturing generic medications in India. The company’s brands, marketed through a team of over 5000, are well recognized by doctors and patients.
