News about "Abbreviated New Drug Application "

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

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

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 |  139

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 |  172

NATCO Announces Approval of its Abbreviated New Drug Application for Everolimus Tablets for Oral Suspension

NATCO Pharma has secured approval for generic Everolimus tablets for oral suspension. The company’s marketing partner for the ANDA, Breckenridge Pharmaceutical plans to launch it in the US market immediately.

Abbreviated New Drug Application | 30/01/2025 | By Abha |  624

Alembic Pharma Gets Tentative Approval for Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent (OTC) has an estimated market size of USD 22 million for twelve months.

Abbreviated New Drug Application | 07/12/2024 | By Aishwarya |  353

Lupin Gets Tentative Approval from FDA for Raltegravir Tablets

Raltegravir Tablets USP, 600 mg are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg.

Abbreviated New Drug Application | 11/11/2024 | By Aishwarya |  302

Alembic Gets FDA Approval for Paliperidone Extended-Release Tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia and it is also indicated for treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Abbreviated New Drug Application | 30/09/2024 | By Aishwarya |  433

Lupin Gets FDA Approval for Bumetanide Injection

Bumetanide Injection USP, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials and 2.5 mg/10 mL (0.25 mg/mL) Multiple-Dose Vials are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Abbreviated New Drug Application | 20/09/2024 | By Aishwarya |  544

Natco Pharma Submits ANDA for Generic Version of TABRECTA

Natco claims to be the first company to have filed a substantially complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of the potential launch of the product under certain circumstances.

Abbreviated New Drug Application | 31/08/2024 | By Aishwarya |  767