Drug business Alembic Pharmaceuticals on Monday stated it has been given a ultimate nod from US wellness regulator for Vilazodone Hydrochloride tablets applied for procedure of depression.
“The enterprise has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug software (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40 mg,” Alembic reported in a filing to BSE.
Vilazodone Hydrochloride tablets are indicated for the treatment of big depressive disorder. “The approved ANDA is therapeutically equivalent to the reference stated drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Profits,” the drug agency stated.
Citing IQVIA, the business claimed Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated current market dimension of USD 469 million for 12 months ending September 2019. Alembic experienced previously acquired tentative approval for this ANDA.
“Alembic was a person of the very first ANDA candidates to post a substantially total ANDA with a paragraph IV certification and hence is qualified for 180 days of shared exclusivity,” it claimed. The launch of the products will be as for every settlement agreement with US-based pharmaceutical company Allergan.