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News about "US Food and Drug Administration (FDA) "
Alembic Wins US FDA Approval for Prucalopride Tablets
Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) approval for generic Prucalopride Tablets, equivalent to Takeda's Motegrity, for Chronic Idiopathic Constipation (CIC).
US Food And Drug Administration (FDA) | 29/07/2026 | By News Bureau | 112
Otsuka Receives US FDA Approval for First-in-Class SIMTRIYO
The US Food and Drug Administration (FDA) has approved Otsuka's SIMTRIYO, the first Norepinephrine, Dopamine, Serotonin Reuptake Inhibitor (NDSRI) for treating ADHD in adults and children aged 6 years and older weighing at least 20 kg.
US Food And Drug Administration (FDA) | 27/07/2026 | By News Bureau
US FDA Approves TYLENOL with Naproxen for OTC Use
The US Food and Drug Administration (FDA) has approved TYLENOL with Naproxen, the first OTC fixed-dose acetaminophen and naproxen combination offering up to 12 hours of pain relief.
US Food And Drug Administration (FDA) | 25/07/2026 | By News Bureau | 167
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.
US Food And Drug Administration (FDA) | 25/03/2026 | By News Bureau | 147
US FDA Delays Two Drug Reviews Under New Priority Voucher Program
The U.S. Food and Drug Administration (FDA) has delayed the review of two medicines selected under its recently launched Commissioner’s National Priority Voucher Program, after regulators raised concerns related to safety and clinical effectiveness.
U.S. Food And Drug Administration (FDA) | 16/01/2026 | By Darshana | 415
FDA Lifts Partial Clinical Hold on Vanda's Tradipitant for Motion Sickness
The lift allows Vanda to extend clinical studies of tradipitant in motion sickness. Meanwhile, the review of the fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track.
US Food And Drug Administration (FDA) | 05/12/2025 | By Dineshwori | 462
Zaynich milestone: First Indian-developed NCE accepted by US FDA
Wockhardt Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
U.S. Food And Drug Administration (FDA) | 02/12/2025 | By Darshana | 989
Ocuvex Resubmits CRL to FDA for PDP-716 NDA, SPARC Reveals
Sun Pharma Advanced Research Company (SPARC) announced that Ocuvex Therapeutics has resubmitted a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of PDP-716.
US Food And Drug Administration (FDA) | 20/11/2025 | By Dineshwori | 569
Ascelia Pharma Strengthens Market Protection for Orviglance with New Patent Filing
Sweden-based biotech company Ascelia Pharma has filed a new patent application for its first-in-class orphan liver imaging drug, Orviglance.
US Food And Drug Administration (FDA) | 10/11/2025 | By Dineshwori | 286
DARZALEX FASPRO is the first and only approved treatment for high-risk smoldering multiple myeloma, according to Johnson & Johnson.
US Food And Drug Administration (FDA) | 07/11/2025 | By Dineshwori | 400
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