Aurobindo receives FDA nod for 3 generics

Aurobindo has received the Food and Drug Administration’s clearance for three generics.

The company received approval for dutasteride & tamsulosin hydrochloride capsules 0.5 mg/0.4 mg, which is the generic of Waylis Therapeutics’ Jalyn.

Dutasteride & tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

Aurobindo also received the FDA’s permission for posaconazole delayed-release tablets 100 mg, which is the generic of Merck, Sharp & Dohme’s Noxafil DR Tablets.

[Read more: Aurobindo given FDA approval for Isotretinoin Capsules]

Posaconazole delayed-release tablets are indicated for the Prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Posaconazole delayed-release tablets have a market value of roughly $68 million for the 12 months ending May 2024, per IQVIA.

Aurobindo’s third FDA approval is for baricitinib tablets, 1 mg and 2 mg, which is the  generic of Eli Lilly’s Olumiant Tablets. 

[Read more: Aurobindo receives FDA approval for 3 generics]

Baricitinib tablets are indicated for the treatment of Rheumatoid Arthritis. Baricitinib Tablets have a market value of approximately $367 million for the 12 months ending May 2024, per IQVIA.