Drug Approval | May 30, 2026
Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months
Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market
Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders
Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market
The product is approved as bioequivalent to Xigduo XR for the indications outlined in the reference drug’s labelling
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