Alembic obtains FDA approval, tentative OK for 2 generics

The Food and Drug Administration has given Alembic clearance for formoterol fumarate inhalation solution, 20 mcg/2 ml per unit-dose vial.

The product is the generic of Mylan Specialty’s Perforomist Inhalation Solution.

The medication is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for lonqterm, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

[Read more: Alembic obtains FDA nod for 2 generics]

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies.

Formoterol fumarate inhalation solution, 20 mcg/2 ml per unit-dose vial, has an estimated market size of $310 million for the 12 months ending September 2021, according to IQVIA.

Alembic also has obtained tentative approval from the FDA for selexipag tablets, in dosage strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg.

The product is the generic of Actelion’s Uptravi.

[Read more: Alembic debuts generic Zebeta]

Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH.

Selexipag tablets have a market value of roughly $461 million for the 12 months ending September 2021, according to IQVIA.