Aurobindo gets FDA nod for 3 generics

Patients with pain that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate have a new generic treatment option available.

The Food and Drug Administration has cleared Aurobindo’s generic oxycodone hydrochloride oral solution in dosage strengths of 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL).

Aurobindo’s product is the generic of Genus Lifesciences’ Oxycodone hydrochloride oral solution, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL).

Oxycodone hydrochloride oral solution has a market value of about $33 million for the 12 months ending December 2019, according to IQVIA.

Patients with certain kinds of severe skin conditions, such as disabling psoriasis, and rheumatoid arthritis also have a new generic treatment option from Aurobindo, now that the FDA has approved methotrexate tablets in a dosage strength of 2.5 mg.

The product is the generic of DAVA Pharmaceuticals’ Rheumatrex tablets, 2.5 mg.

Methotrexate tablets have a market value of roughly $97.7 million for the 12 months ended December 2019, according to IQVIA.

Finally, patients with major depressive disorder have a new generic drug available. The FDA has given its blessing to Aurobindo for trazodone hydrochloride tablets, in dosage strengths of 50 mg, 100 mg, 150 mg, and 300 mg.

Aurobindo’s product is the generic of Pragma’s Desyrel tablets, 50 mg, 100 mg, 150 mg, and 300 mg.

Trazodone hydrochloride tablets have a market value of $123 million for the 12 months ending December 2019, according to IQVIA.