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Shilpa Medicare gets USFDA nod for arthritis drug

Shilpa Medicare has received United States Food and Drug Administration (USFDA)s tentative approval for its abbreviated new drug application (ANDA), apremilast tablets, 10 mg, 20 mg, and 30 mg. The ANDA was filed as First to File submission on NCE -1 date to seek eligibility for 180 days exclusivity. Apremilast tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene, used in the treatment of psoriatic arthritis as recommended in the label appro...
United States Drug Administration Shilpa Medicare United States Food Capital Market Branches Of Biology

Alembic Pharma rises after USFDA nod for orthostatic hypotension drug

Alembic Pharmaceuticals gained 0.59% to Rs 956.4 after the drug maker received the US drug regulators approval for midodrine hydrochloride tablets.Alembic Pharmaceuticals (Alembic) on 22 January 2020 announced that it received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) midodrine hydrochloride tablets USP, 2.5 mg, 5 mg, and 10 mg. The drug is indicated for the treatment of symptomatic orthostatic hypotension (OH). The approved ANDA is ...
Takeda Pharmaceuticals United States Inc Alembic Pharmaceuticals Us Food Drug Administration Drug Administration Abbreviated New Drug Application Takeda Pharmaceuticals United States

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Alembic Pharmaceuticals receives USFDA approval for Midodrine Hydrochloride Tablets

Alembic Pharmaceuticals announced that it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hyp...
Takeda Pharmaceuticals United States Inc Alembic Pharmaceuticals Us Food Drug Administration Drug Administration Abbreviated New Drug Application Midodrine Hydrochloride Tablets

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