Sentynl
FDA Approves NULIBRY — Sentynl Therapeutics, Inc.
# FDA Approval Newswire **Sentynl Therapeutics Receives FDA Approval for NULIBRY (Fosdenopterin Hydrobromide), Expanding Treatment Options in Rare Di...
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Amgen
FDA Approves REPATHA — Amgen USA Inc.
Amgen announced the FDA approval of its viocumab (Repatha) for a pediatric indication on February 26, promising to expand its lipid-lowering market sh...
Dr.
FDA Approves VIGABATRIN — Dr. Reddys Laboratories Inc.,
# FDA Approves Dr. Reddy's Laboratories Vigabatrin Generic, Expanding Market Competition Dr. Reddy's Laboratories Inc. has received FDA approval for ...
Sigmapharm
FDA Approves ASENAPINE — Sigmapharm Laboratories, LLC
Sigmapharm Laboratories secured FDA approval for its generic, sublingual Asenapine tablets, a development expected to increase generic market penetrat...
Dr.
FDA Approves CAPECITABINE — Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited received FDA approval for its generic capecitabine, an oral chemotherapy agent, strengthening its position in the U.S...
Ingenus
FDA Approves SCOPOLAMINE — Ingenus Pharmaceuticals, LLC
# FDA Approves Ingenus Pharmaceuticals' Generic Scopolamine Transdermal Patch Ingenus Pharmaceuticals, LLC has received FDA approval for its generic ...
ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE
# FDA Approves Generic Drug Application for Accord Healthcare Accord Healthcare received FDA approval for ANDA 214425 on November 13, 2020, expanding...
Aurobindo
FDA Approves POMALIDOMIDE — Aurobindo Pharma Limited
# FDA Approves Generic Pomalidomide; Aurobindo Pharma Enters Multiple Myeloma Market Aurobindo Pharma Limited received FDA approval for its generic p...
Natco
FDA Approves POMALIDOMIDE — Natco Pharma Limited
On October 30, 2020, Natco Pharma Limited received approval from the FDA for its generic version of the oral drug pomalidomide under ANDA210111, a mov...
Leading
FDA Approves LEUCOVORIN CALCIUM — Leading Pharma, LLC
Leading Pharma, LLC received FDA approval for generic oral Leucovorin Calcium, introducing a new entrant that is expected to intensify competition and...
Gilead
FDA Approves VEKLURY — Gilead Sciences, Inc.
The FDA’s approval of Gilead Sciences, Inc.’s intravenous remdesivir (VEKLURY) marks a significant milestone for the company’s antiviral portfolio, po...
Harmony
FDA Approves WAKIX — Harmony Biosciences, LLC
# FDA Approves Harmony Biosciences' WAKIX for Narcolepsy Treatment Harmony Biosciences announced FDA approval of WAKIX (pitolisant hydrochloride), an...
Lifestar
FDA Approves ACETAZOLAMIDE — Lifestar Pharma LLC
# FDA Approves Lifestar Pharma's Generic Acetazolamide The U.S. Food and Drug Administration has approved Lifestar Pharma LLC's abbreviated new drug ...
SpecGx
FDA Approves DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — SpecGx LLC
SpecGx LLC has secured FDA approval for the generic oral formulation of Diphenoxylate Hydrochloride and Atropine Sulfate, positioning the company to e...
Pfizer
FDA Approves XELJANZ — Pfizer Laboratories Div Pfizer Inc
Pfizer’s FDA approval of XELJANZ reinforces its competitive position in the rheumatology market, expected to drive incremental sales growth as it capt...
Avet
FDA Approves ACYCLOVIR — Avet Pharmaceuticals Inc.
Avet Pharmaceuticals Inc. announced FDA approval of its Abbreviated New Drug Application for oral acyclovir, potentially strengthening its position in...
Celgene
FDA Approves ONUREG — Celgene Corporation
# FDA Approves Celgene's ONUREG (Azacitidine) as First Oral Maintenance Therapy for AML The FDA approval of Celgene Corporation's ONUREG (azacitidine...
TruPharma,
FDA Approves TRAMADOL HYDROCHLORIDE — TruPharma, LLC
TruPharma, LLC announced on Monday the implementation of the 180-day generic exclusivity period for its 50 mg and 100 mg oral tramadol hydrochloride t...
ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE
Accord Healthcare announced FDA approval for a new drug application on Aug. 24, 2020, which market analysts expect to broaden the company’s product po...
Zhejiang
FDA Approves GABAPENTIN — Zhejiang Yongtai Pharmaceutical Co., Ltd
# FDA Approves Generic Gabapentin from Zhejiang Yongtai Pharmaceutical The U.S. Food and Drug Administration has approved Zhejiang Yongtai Pharmaceut...