News about "Abbreviated New Drug Application "

Morepen Labs Makes First US ANDA Submission

Morepen strengthens its CDMO capabilities with its first US ANDA submission, expanding formulation, bioequivalence and regulatory expertise for regulated markets.

Abbreviated New Drug Application | 30/09/2026 | By News Bureau

Alembic Pharmaceuticals Announces US FDA Tentative Approval for Binimetinib Tablets, 45 mg

Alembic Pharmaceuticals has received the US Food and Drug Administration (FDA) tentative approval for Binimetinib Tablets 45 mg, a generic version of Mektovi (binimetinib).

Abbreviated New Drug Application | 20/06/2026 | By News Bureau |  169

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

Abbreviated New Drug Application | 07/04/2026 | By News Bureau |  205

Lupin Limited Secures US FDA Approval for Generic Brivaracetam Oral Solution

Lupin has received US FDA approval for its generic brivaracetam oral solution, bioequivalent to Briviact, and has launched the product in the US market targeting partial-onset seizures.

Abbreviated New Drug Application | 25/02/2026 | By News Bureau |  364

Alembic Pharmaceuticals Wins US FDA Approval for Generic Efinaconazole Topical Solution

Alembic Pharmaceuticals receives US FDA approval for generic efinaconazole topical solution, targeting a US market estimated at USD 500 million.

Abbreviated New Drug Application | 24/02/2026 | By News Bureau |  409

Indoco Remedies Secures US FDA Approval for Generic Brivaracetam Oral Solution

Indoco Remedies receives US FDA approval to market generic brivaracetam oral solution for partial-onset seizures in the US market.

Abbreviated New Drug Application | 24/02/2026 | By News Bureau |  217

Bionpharma Wins FDA Approval for Etravirine Tablets in Partnership with STEERLife

The US FDA approval clears the way for Bionpharma to market its generic Etravirine tablets in the US, expanding patient access to a cost-effective HIV treatment option.

Abbreviated New Drug Application | 14/01/2026 | By News Bureau |  202

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.

Abbreviated New Drug Application | 12/01/2026 | By News Bureau |  268

USFDA Approves Alembic Pharmaceuticals' Sumatriptan Single-Dose Autoinjector

Alembic Pharmaceuticals has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan single-dose autoinjector, deemed therapeutically equivalent to GlaxoSmithKline’s Imitrex STATdose System in 4 mg/0.5 mL and 6 mg/0.5 mL strengths.

Abbreviated New Drug Application | 10/11/2025 | By Dineshwori |  265

Alembic Pharmaceuticals Secures USFDA Final Approval for Phytonadione Injectable Emulsion

Alembic Pharmaceuticals has received final USFDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, used in treating and preventing vitamin K deficiency-related conditions.

Abbreviated New Drug Application | 09/09/2025 | By Mrinmoy Dey |  310