News about "Abbreviated New Drug Application (ANDA) "

Granules Gains First-to-File Status for Ruxolitinib ER Tablets

Granules India has filed a Paragraph IV certification for Ruxolitinib Extended-Release (ER) Tablets, and may qualify for first-to-file status.

Abbreviated New Drug Application (ANDA) | 09/10/2026 | By News Bureau |  226

Lupin Announces Approval from US FDA for Pitolisant Tablets

Lupin receives US Food and Drug Administration (FDA) approval for Pitolisant Tablets, 4.45 mg and 17.8 mg, a generic version of Wakix, for indications covered by the approved labeling.

Abbreviated New Drug Application (ANDA) | 17/08/2026 | By News Bureau |  101

Sun Pharma Reports Q1FY27 Results

Sun Pharma reported a 10.1 percent YoY rise in Q1 FY27 sales to INR 151,836 million, while net profit increased to INR 28,948 million, driven by strong business growth.

Abbreviated New Drug Application (ANDA) | 01/08/2026 | By News Bureau |  240

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.

Abbreviated New Drug Application (ANDA) | 02/06/2026 | By News Bureau |  123

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.

Abbreviated New Drug Application (ANDA) | 25/03/2026 | By News Bureau |  175

Biocon Receives US FDA Approval for Everolimus Tablets for Oral Suspension

Biocon has secured US FDA approval for Everolimus Tablets for Oral Suspension, enhancing its portfolio of vertically integrated drug products and expanding treatment options for patients in key markets.

Abbreviated New Drug Application (ANDA) | 13/01/2026 | By News Bureau |  217

Granules Pharmaceuticals Secures US FDA Tentative Approval for gDYANAVEL XR

The tentative approval clears a key regulatory milestone for Granules Pharmaceuticals’ Abbreviated New Drug Application (ANDA), which the US FDA has determined to be eligible for 180-day market exclusivity.

Abbreviated New Drug Application (ANDA) | 09/01/2026 | By News Bureau |  203

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.

Abbreviated New Drug Application (ANDA) | 18/12/2025 | By News Bureau |  177

Alembic Pharmaceuticals Receives USFDA Approval for Generic Dasatinib Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Abbreviated New Drug Application (ANDA) | 07/11/2025 | By Dineshwori |  569

Alembic Pharmaceuticals Secures USFDA Approval for Ticagrelor Tablets, 60 mg

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is therapeutically equivalent to Brilinta Tablets, 60 mg, from AstraZeneca.

Abbreviated New Drug Application (ANDA) | 29/10/2025 | By Dineshwori |  405