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Rhodes Pharmaceuticals LLC announced today that its application (ANDA205601) for the generic sublingual combination of buprenorphine and naloxone has been granted FDA approval, a m…
Laurus Labs Limited announced the approval of the ANDA for fenofibrate oral tablets, enabling it to compete in the U.S. cholesterol-lowering market following product label patent e…
VistaPharm, LLC announced the FDA approval of its methadone hydrochloride oral solution, effectively adding a new competitor to the market for a controlled substance that has histo…
The FDA approved Lundbeck’s intravenous CGRP inhibitor VYEPTI for the prevention of episodic migraine, positioning the company to capitalize on the lucrative and rapidly growing mi…
Agile Therapeutics, Inc. secured FDA approval for Twirla (levonorgestrel/ethinyl estradiol) transdermal gel, positioning the company to compete in a crowded contraceptive market by…
Pharmaceutical manufacturer SANALUZ announced FDA approval for a generic drug via ANDA 211690, a strategic milestone that is expected to bolster the company's market share and driv…
Chartwell RX, LLC announced the FDA approval of its generic methotrexate sodium tablets for the treatment of several conditions, positioning the company to compete in the establish…
Aurolife Pharma, LLC received FDA approval for its oxycodone hydrochloride oral solution, a development expected to bolster generic competition and potentially improve supply avail…
Accord Healthcare Inc. has won FDA approval for the generic version of methotrexate sodium, widening the competitive landscape for this widely prescribed oncology and rheumatoid ar…
Alvogen Inc. filed a new generic application (ANDA206986) for oral hydrocodone bitartrate on January 21, 2020. This approval is expected to intensify competition in the generic nar…
Granules Pharmaceuticals Inc. announced the FDA approval of its ANDA for Hydrocodone Bitartrate and Acetaminophen, granting the company a strategic entry into the established analg…
# FDA Approves Daiichi Sankyo's ENHERTU for HER2-Positive Cancers The FDA has approved Daiichi Sankyo Inc.'s ENHERTU (fam-trastuzumab deruxtecan-nxki), an intravenous HER2-targete…
The U.S. FDA has approved the INDICATION for Enfortumab Vedotin (Padcev EJFV) for INITIATED TREATMENT of LOCALIZED MUSCOSAL SQUAMOUS CELL CARCINOMA (UCSCC), DEVELOPED BY SEAGEN INC…
Concord Biotech Limited announced the FDA approval of its ANDA for Mycophenolate Sodium Oral Suspension, providing a crucial oral bioequivalent to Mycophenolate Sodium USP. This au…
# FDA Approves Vigabatrin Generic from Cipla USA Cipla USA, Inc. received FDA approval for its generic vigabatrin oral formulation, expanding the competitive landscape for this se…
Shionogi Inc. announced the FDA approval of FETROJA (cefiderocol sulfate tosylate) Intravenous injection for the treatment of certain hospital-acquired bacterial pneumonia and vent…
Sun Pharmaceutical Industries, Inc. secured FDA approval for oral isotretinoin brand Absorica LD, positioning the Indian pharma giant to capture significant market share within the…
Sandoz Inc. has secured FDA approval for the biosimilar PEGFILGRASTIM-BMEZ (ZIEXTENZO), filling a major void in the market for a subcutaneous granulocyte colony-stimulating factor …
The U.S. FDA has approved oral palbociclib (IBRANCE, NDA212436) manufactured by U.S. Pharmaceuticals, a move that broadens the accessibility of this widely utilized CDK4/6 inhibito…
ScieGen Pharmaceuticals, Inc. has received FDA approval for its Abbreviated New Drug Application for Naproxen Sodium, launching an additional generic entry into the pain relief mar…