FDA Approves ZOLEDRONIC ACID — Eugia US LLC
# FDA Approves Generic Zoledronic Acid Intravenous Formulation Eugia US LLC has received FDA approval for its generic zoledronic acid intravenous formulation (ANDA209125), expandi…
SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.
# FDA Approves Generic Zoledronic Acid Intravenous Formulation Eugia US LLC has received FDA approval for its generic zoledronic acid intravenous formulation (ANDA209125), expandi…
# FDA Approves Novo Nordisk's Ozempic for Type 2 Diabetes Treatment Novo Nordisk Pharmaceutical Industries, LP received FDA approval for Ozempic (semaglutide), a once-weekly subcu…
Zhejiang Hisun Pharm has received FDA approval for the generic version of S Combipres (ncludpril & clonidine) indicated for hypertension, securing a significant competitive foothol…
AstraZeneca announced on November 14, 2017, that the FDA granted full approval for its blockbuster respiratory drug FASENRA, the subcutaneous formulation of benralizumab. This appr…
# FDA Approves AstraZeneca's CALQUENCE (acalabrutinib) for Blood Cancer Treatment AstraZeneca Pharmaceuticals LP received FDA approval for CALQUENCE (acalabrutinib), an oral Bruto…
Eywa Pharma Inc secured FDA approval for its ANDA 210211 covering Hydrocodone Bitartrate and Acetaminophen oral tablets, thereby granting the company a license to manufacture a gen…
1. **Analyze the Request:** * **Topic:** FDA drug approval (generic hydromorphone hydrochloride). * **Key Data:** * Brand/Substance: Hydromorphone Hydrochlor…
On September 25, 2017, Lannett Company received FDA approval for a generic drug indicated by ANDA207333, positioning the company for potential market capture despite unspecified su…
# FDA Approves Actelion Pharmaceuticals' TRACLEER (bosentan) Oral Formulation Actelion Pharmaceuticals US, Inc. received FDA approval for TRACLEER (bosentan) oral formulation unde…
ANI PHARMS announced August 30, 2017, approval of ANDA 203447 for a generic substance, potentially challenging the current market supply as the company prepares to introduce the th…
PHARM ASSOC announced an FDA approval for ANDA206822 on August 15, 2017, signaling progress in the company's product pipeline; this regulatory clearance is expected to bolster the …
# FDA Approves Zydus Pharmaceuticals' Generic Diltiazem Hydrochloride Zydus Pharmaceuticals (USA) Inc. received FDA approval for its generic diltiazem hydrochloride oral formulati…
Hikma announced FDA approval for its ANDA 208795, a regulatory milestone expected to bolster the company’s commercial pipeline and drive future revenue growth.
Janssen Biotech announced today that the FDA has approved GUSELKUMAB (TREMFYA), a subcutaneous anti-IL-23r antibody, following a standard six-week review rather than the initial pr…
# FDA Approves Generic Drug Application for Hikma Pharmaceuticals Hikma Pharmaceuticals received FDA approval for ANDA 208809 on July 6, 2017, expanding its generic drug portfolio…
# FDA Approves Generic Drug Application for Actavis Labs FL Inc Actavis Labs FL Inc received FDA approval for ANDA207139 on June 20, 2017, positioning the company to capture marke…
1. **Analyze the Request:** * **Topic:** FDA drug approval. * **Input Data:** * Brand: N/A * Generic: N/A * Substance: [Missing from prom…
Lannett Co. Inc. has received FDA approval for ANDA 207171, which is expected to bolster its generic portfolio and contribute incremental revenue as the product enters the market.
Lupin Pharmaceuticals, Inc. received FDA approval for its Oxycodone Hydrochloride generic on June 12, 2017, securing a position in the competitive opioid market and positioning the…
# FDA Approves Generic Drug Application for Sagent Pharmaceuticals Sagent Pharmaceuticals Inc. received FDA approval for ANDA 203608 on May 11, 2017, expanding its generic drug po…