News about "Reference Listed Drug (RLD) "

Glenmark Launches Calcium Gluconate Injection in US

Glenmark launches Calcium Gluconate Injection USP in the US, offering a bioequivalent and therapeutically equivalent alternative to Fresenius Kabi’s reference drug.

Reference Listed Drug (RLD) | 21/08/2026 | By News Bureau

Lupin Secures US Approval for Sodium Zirconium Cyclosilicate Oral Suspension

Lupin has received US Food and Drug Administration (FDA) approval for Sodium Zirconium Cyclosilicate Oral Suspension, 5 g and 10 g, bioequivalent to AstraZeneca’s Lokelma.

Reference Listed Drug (RLD) | 11/08/2026 | By News Bureau

Glenmark Launches Generic Sugammadex Injection in US

Glenmark has launched generic Sugammadex Injection in the US, a bioequivalent and therapeutically equivalent version of Merck's BRIDION Injection.

Reference Listed Drug (RLD) | 29/07/2026 | By News Bureau

Lupin Launches Azilsartan Medoxomil Tablets in US

Lupin has launched Azilsartan Medoxomil Tablets in the US, a bioequivalent generic version of Edarbi, indicated for the treatment of hypertension in adults.

Reference Listed Drug (RLD) | 17/06/2026 | By News Bureau |  111

Lupin Receives US FDA Approval for Sodium Sulfate, Magnesium Sulfate and Potassium Chloride Tablets

Lupin has received US FDA approval for its Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, a bioequivalent to Reference Listed Drug (RLD) Sutab Tablets of Azurity Pharmaceuticals.

Reference Listed Drug (RLD) | 02/06/2026 | By News Bureau |  106

Glenmark Specialty SA Receives US FDA Approval for Fluticasone Propionate Inhalation Aerosol USP

Glenmark Pharmaceuticals’s subsidiary Glenmark Specialty SA has received approval from the US Food and Drug Administration (FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, along with 180-day Competitive Generic Therapy exclusivity. The product has been deemed bioequivalent and therapeutically equivalent to Flovent HFA.

Reference Listed Drug (RLD) | 05/03/2026 | By Akanki |  165

Zydus Gets USFDA Tentative Nod for Dapagliflozin Tablets

Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for dapagliflozin tablets in 5 mg and 10 mg strengths, paving the way for the company’s entry into the US market subject to final approval.

Reference Listed Drug (RLD) | 06/02/2026 | By News Bureau |  184

Alembic Pharma Secures US FDA Tentative Approval for Bosutinib Tablets

The USFDA’s tentative approval confirms that Alembic Pharmaceuticals’ Bosutinib Tablets, 400 mg, meet therapeutic equivalence requirements with the Reference Listed Drug (RLD) Bosulif, marking an important step towards potential market entry.

Reference Listed Drug (RLD) | 12/01/2026 | By News Bureau |  248

Glenmark Launches Epinephrine Injection Multi-Dose Vial

Glenmark has introduced its Epinephrine Injection USP, 1?mg/mL, 30?mg/30?mL multiple-dose vial, which is bioequivalent and therapeutically equivalent to the reference drug by BPI Labs, LLC (NDA 205029), offering a reliable alternative for patients and healthcare providers.

Reference Listed Drug (RLD) | 23/12/2025 | By News Bureau |  202

Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.

Reference Listed Drug (RLD) | 18/12/2025 | By News Bureau |  155