Alembic gets FDA nod for two generics

Patients with certain bacterial infections have a new generic treatment option. The Food and Drug Administration has cleared Alembic’s azithromycin tablets in a dosage strength of 600 mg.

Alembic’s azithromycin tablets is the generic of Pfizer’s Zithromax tablets, 600 mg.

The product is indicated for mild to moderate infections in chronic bronchitis in adults; acute bacterial sinusitis in adults; uncomplicated skin and skin structure infections in adults; urethritis and cervicitis in adults; genital ulcer disease in men; community-acquired pneumonia in adults and pharyngitis/tonsillitis in adults.

Azithromycin tablets, 600 mg have a market value of roughly $2 million for the 12 months ended September 2019 according to IQVIA.

Alembic also garnered the FDA’s blessing for bosentan tablets, in dosage strengths of 62.5 mg and 125 mg. This approval provides a treatment option for patients with pulmonary arterial hypertension.

The product is the generic of Actelion’s Tracleer tablets, 62.5 mg and 125 mg

Bosentan tablets, 62.5 mg and 125 mg have a market value of approximately $68 million for the 12 months ended September 2019, according to IQVIA.