Drug Approval | May 20, 2026
Lupin gets tentative FDA nod for Revefenacin inhalation solution
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
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
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
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
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
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