FDA Approves FEXOFENADINE HYDROCHLORIDE — Aurohealth LLC
**Aurohealth LLC received FDA approval on May 23 for its ANDA 213466 for FEXOFENADINE HYDROCHLORIDE Oral, introducing an additional generic alternative to the widely subscribed ant…
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**Aurohealth LLC received FDA approval on May 23 for its ANDA 213466 for FEXOFENADINE HYDROCHLORIDE Oral, introducing an additional generic alternative to the widely subscribed ant…
Genmab US, Inc. received FDA approval on May 19, 2023, for EPKINLY (epcoritamab-bysp), a bispecific CD3xCD20 antibody administered subcutaneously, which may broaden access compared…
Camber Pharmaceuticals, Inc. announced the FDA’s approval of its ANDA for oral Lenalidomide, granting the company a license to market a generic version of the drug and intensifying…
# FDA Approves WG Critical Care's Intravenous Cefazolin Formulation WG Critical Care, LLC received FDA approval for its intravenous cefazolin sodium injection (NDA211413), a broad…
On April 28, 2023, AstraZeneca received FDA approval for its experimental anti-inflammatory drug, a landmark clearance likely to enhance the company's position in the rapidly growi…
NATCO announced today that the FDA has approved Abbreviated New Drug Application (ANDA) 213267, dated April 27, 2023. This regulatory clearance is expected to reshape market dynami…
# FDA Approves GlaxoSmithKline's ZEJULA (Niraparib Tosylate) for Oral Administration GlaxoSmithKline LLC has received FDA approval for ZEJULA (niraparib tosylate), an oral PARP in…
Vertex Pharmaceuticals Incorporated secured FDA approval for TRIKAFTA, reinforcing the company’s market dominance in the cystic fibrosis sector and driving revenue forecasts as the…
NorthStar Rx LLC received FDA approval for its Abbreviated New Drug Application (ANDA #216385) for oral nitrofurantoin, enabling the launch of a generic version of the antibiotic. …
ScieGen Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application (ANDA) 216327, granting it market rights to the generic version of Diltiazem Hydrochloride…
Oncedem Pharmaceuticals (formerly Aurobindo Pharma) announced the approval of its generic pregabalin tablets, a move expected to position the company as a major player in the US ma…
On Thursday, the FDA granted approval to Pharming’s **[New Drug Name]**, potentially targeting the significant unmet need in **[Indication]**, though the commercial viability will …
# FDA Approves Incyte's ZYNYZ (retifanlimab-dlwr), Expanding the Company's Oncology Portfolio Incyte Corporation announced FDA approval of ZYNYZ (retifanlimab-dlwr), an intravenou…
Novartis faces heightened competitive pressure as the FDA approves generic Dabrafenib mesylate for oral use, threatening to undermine the revenue of the company's branded TAFINLAR …
Novartis Pharmaceuticals Corporation has received FDA approval for MEKIST (trametinib) dimethyl sulfoxide, marking an update to an existing product line. This approval retains the …
Zydus Pharmaceuticals USA Inc. secured FDA approval for its generic version of Tofacitinib Citrate, positioning the firm to capture significant market share and drive additional re…
# FDA Approves Acadia Pharmaceuticals' DAYBUE (trofinetide) for Rare Neurological Disorder Acadia Pharmaceuticals Inc. received FDA approval for DAYBUE (trofinetide), an oral trea…
# FDA Approves Generic Lurasidone Hydrochloride; Aurobindo Pharma Enters Antipsychotic Market Aurobindo Pharma Limited has received FDA approval for its generic formulation of lur…
Teva Pharmaceuticals announced on March 10, 2023, the FDA approval of its generic version of FDA-approved with its High Blood Pressure drugs (HBP) and epilepsy. This approval allow…
International Medication Systems, Ltd. received FDA approval for its nasally administered naloxone hydrochloride (Rextovy, NDA208969) on March 7, 2023, potentially expanding the co…