Alembic Pharmaceuticals up 2.7% after receiving USFDA Final Approval for Nelarabine Injection, 250 mg/50 mL.

The company reported that the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection, 250 mg/50 mL (5 mg/mL), belonging to Sandoz.

Alembic Pharma stated that Nelarabine is used in the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Nelarabine is a nucleoside metabolic inhibitor and can be used for adult and pediatric patients aged 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Alembic Pharma cited IQVIA’s sales data for the year ending March 2024 and stated that Nelarabine Injection, 250 mg/50 mL has an estimated market size of $23 million.

Last week, the company announced that the US FDA had completed its inspection at the company’s Oral Solid Formulation Facility (F-I) located at Panelav. The Good Manufacturing Practice (GMP) Inspection was scheduled to be conducted from 17 July 2024 to 26 July 2024. The inspection concluded with zero Form 483 observations.

Further, the company announced that it has received final approval from the US FDA for its ANDA Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg. Fluphenazine Hydrochloride tablets are indicated for the management of manifestations of psychotic disorders.

As of August 2, 2024, Alembic Pharmaceuticals has a total of 211 ANDA approvals from the US FDA, of which 183 have received final approval while 28 have received tentative approvals.

Shares of the company have risen by nearly 63% since the beginning of the year. The stock has gained over 61% in the past year.