News about "Abbreviated New Drug Application "

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

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 |  308

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 |  210

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 |  190

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 |  327

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 |  401

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 |  417

Amneal Secures FDA Approval for Propofol Injectable Emulsion Single Dose Vials

Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation.

Abbreviated New Drug Application | 21/08/2024 | By Aishwarya |  370

Alembic Pharmaceuticals Gets FDA Approval for Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. Refer label for a detailed indication.

Abbreviated New Drug Application | 16/08/2024 | By Aishwarya |  366

Granules India Gets ANDA Approval for Trazodone Tablets

Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval). The current annual US market for Trazodone tablets is approximately USD 128 Million.

Abbreviated New Drug Application | 12/08/2024 | By Aishwarya |  353