Aurobindo receives FDA OK for 2 generics

Aurobindo has received the Food and Drug Administration’s green light for lansoprazole delayed-release orally disintegrating tablets, 15 mg and 30 mg, which are the generic of Takeda’s Prevacid SoluTab. 

Lansoprazole delayed-release orally disintegrating tablets are indicated for the following:

• Short-term treatment of active duodenal ulcer;
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence;
• Maintenance of healed duodenal ulcers;
• Short-Term treatment of active benign gastric ulcer;
• Healing of nonsteroidal anti-inflammatory drugs - associated gastric ulcer;
• Risk reduction of NSAID-associated gastric ulcer;
• Gastroesophageal reflux disease;
• Maintenance of healing of erosive esophagitis; and
• Pathological hypersecretory conditions including Zollinger-Ellison syndrome.  

Lansoprazole delayed-release orally disintegrating tablets have a market value of roughly $32.8 million for the 12 months ending January 2023, according to IQVIA.

The FDA also has approved Aurobindo’s Prazosin hydrochloride capsules, 1 mg, 2 mg and 5 mg, which are the generic of Pfizer’s Minipress. 

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

The medication is indicated for the treatment of hypertension to lower blood pressure.

Prazosin hydrochloride capsules have a market value of roughly $46.8 million for the 12 months ending February 2023, according to IQVIA.

[Read more: Aurobindo obtains FDA OK for 2 generics]