FDA clear 2 generics from Alembic

Patients with various skin conditions have a new generic drug treatment option. The Food and Drug Administration has approved Alembic’s joint venture Aleor Dermaceuticals’clobetasol propionate cream in a dosage strength of 0.05%.

Alembic’s clobetasol propionate is the generic of Fourgera’s Temovate cream, 0.05%.

The super-high potency corticosteroid formulation is indicated for the relief of the inflammatory and pruritic manifestations.

Clobetasol propionate cream has a market value of approximately $57 million for the 12 months ending September 2019, according to IQVIA.

There's also a new generic treatment available for patients with certain bacterial infections, following the FDA’s approval of Alembic's azithromycin tablets in dosage strengths of 250 mg and 500 mg.

The product is the generic of Pfizer’s Zithromax tablets, 250 mg and 500 mg.

On Tuesday, Alembic also received the FDA’s approval for azithromycin tablets in a dosage strength of 600 mg.

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

Azithromycin tablets, 250 mg and 500 mg have a market value of roughly $129 million for the 12 months ended September 2019, according to IQVIA.