Nova
FDA Approves MERCAPTOPURINE — Nova Laboratories, Ltd
Nova Laboratories has received FDA approval for the oral formulation of mercaptopurine (NDA205919), expanding an existing treatment portfolio during t...
Financial News Archive
SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
SENORES
FDA Approves Unknown Drug — SENORES PHARMS
Senores Pharma secured FDA approval for its generic product, a move that is expected to bolster the company’s revenue stream while introducing immedia...
Lantheus
FDA Approves NEURACEQ — Lantheus Biosciences Ltd., a Lantheus company
Lantheus Biosciences has received FDA approval of NEURACEQ® (florbetaben F 18), a molecular imaging agent indicated for the detection of amyloid plaqu...
Upsher-Smith
FDA Approves TOPIRAMATE — Upsher-Smith Laboratories, LLC
# FDA Approves Upsher-Smith's Topiramate Oral Formulation Upsher-Smith Laboratories, LLC received FDA approval for its oral topiramate formulation (N...
Lupin
FDA Approves DOXYCYCLINE — Lupin Pharmaceuticals, Inc.
Lupin Pharmaceuticals, Inc. secured FDA approval on March 5, 2014, for its generic Doxycycline oral tablets, positioning the company to capture market...
Washington
FDA Approves AMMONIA N 13 — Washington University School of Medicine
# FDA Approval Newswire Washington University School of Medicine has received FDA approval for AMMONIA N-13 (NH3N13), an intravenous diagnostic radio...
SANKALP
FDA Approves Unknown Drug — SANKALP LIFECARE
Sankalp Lifecare announced FDA approval for its new drug application, a milestone that is expected to diversify the company's revenue streams and stre...
AstraZeneca
FDA Approves FARXIGA — AstraZeneca Pharmaceuticals LP
# FDA Approves AstraZeneca's FARXIGA for Diabetes Treatment AstraZeneca Pharmaceuticals LP received FDA approval for FARXIGA (dapagliflozin), an oral...
SUN
FDA Approves Unknown Drug — SUN PHARM INDS INC
Sun Pharma received FDA approval for an Abbreviated New Drug Application, a regulatory clearance expected to facilitate generic market entry and drive...
Par
FDA Approves ADRENALIN — Par Health USA, LLC
Par Health USA, LLC has secured FDA approval for injection, epinephrine, intended for the management of severe allergic reactions, historically openin...
Mylan
FDA Approves AMLODIPINE AND ATORVASTATIN — Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. received FDA approval for its generic version of the cardiovascular drug Amlodipine and Atorvastatin, offering a cost-effec...
Fresenius
FDA Approves MORPHINE SULFATE — Fresenius Kabi, USA LLC
Fresenius Kabi secured FDA approval for its intramuscular morphine sulfate formulation, significantly expanding its therapeutic options within the com...
Westminster
FDA Approves METFORMIN HYDROCHLORIDE — Westminster Pharmaceuticals, LLC
Westminster Pharmaceuticals, LLC announced final FDA approval today for its ANDA 203769, aiming to introduce metformin hydrochloride tablets to the ma...
AUROLIFE
FDA Approves Unknown Drug — AUROLIFE PHARMA LLC
# FDA Approves ANDA for AUROLIFE PHARMA LLC AUROLIFE PHARMA LLC has received FDA approval for ANDA 202580, expanding its generic drug portfolio and p...
HIKMA
FDA Approves Unknown Drug — HIKMA
HIKMA Pharmaceuticals announced the FDA approval of its Generic ANDA application, a strategic milestone expected to bolster market share and expand re...
HIKMA
FDA Approves Unknown Drug — HIKMA
HIKMA announced early FDA approval for its generic version of this pharmaceutical product on July 12, 2013, positioning itself to compete in this spec...
PH
FDA Approves Unknown Drug — PH HEALTH
PH HEALTH has secured FDA approval for the pending generic application ANDA090733, a move that positions the company to capture new market share and d...
ACTAVIS
FDA Approves Unknown Drug — ACTAVIS ELIZABETH
Actavis Elizabeth’s FDA approval of this ANDA clears the regulatory path for a generic entry, positioning the company to compete aggressively against ...
PH
FDA Approves Unknown Drug — PH HEALTH
On July 11, 2013, PH HEALTH received FDA approval for ANDA090734, introducing a new therapeutic option to the market. This clearance is expected to ge...
Sun
FDA Approves FINASTERIDE — Sun Pharmaceutical Industries, Inc.
# FDA Approves Sun Pharmaceutical's Generic Finasteride Sun Pharmaceutical Industries, Inc. received FDA approval for its generic finasteride formula...