SANDOZ
FDA Approves Unknown Drug — SANDOZ
The FDA’s approval of a generic pharmaceutical from SANDOZ is poised to strengthen the company’s market presence and drive revenue growth, however, th...
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ACTAVIS
FDA Approves Unknown Drug — ACTAVIS LABS FL INC
On March 22, 2011, Actavis Labs Fl Inc received FDA approval for ANDA090084, a generic drug anticipated to drive incremental sales in the specific the...
Bayer
FDA Approves GADAVIST — Bayer HealthCare Pharmaceuticals Inc.
# FDA Approves Bayer's Gadavist (Gadobutrol) for MRI Contrast Imaging Bayer HealthCare Pharmaceuticals Inc. received FDA approval for Gadavist (gadob...
TEVA
FDA Approves Unknown Drug — TEVA
Teva Pharmaceutical Industries received FDA approval on Thursday for Nifedipine Extended Release Tablets, extending its reach within the cardiovascula...
SpecGx
FDA Approves FENTANYL TRANSDERMAL — SpecGx LLC
SpecGx LLC announced the FDA approval of the Fentanyl Transdermal ANDA (App # ANDA077154) on February 9th, potentially expanding generic competition f...
SENORES
FDA Approves Unknown Drug — SENORES PHARMS
Senores Pharma has secured FDA approval for its Abbreviated New Drug Application (ANDA090404), a pivotal development expected to bolster the company's...
Medi-Physics
FDA Approves DATSCAN — Medi-Physics Inc. dba GE Healthcare.
# FDA Approves GE Healthcare's DaTscan for Parkinson's Disease Diagnosis GE Healthcare's Medi-Physics division received FDA approval for DaTscan (iof...
Alembic
FDA Approves LAMOTRIGINE — Alembic Pharmaceuticals Limited
# FDA Approves Alembic Pharmaceuticals' Generic Lamotrigine Alembic Pharmaceuticals Limited has received FDA approval for its generic lamotrigine ora...
RISING
FDA Approves Unknown Drug — RISING
# FDA Approval Newswire Rising Pharmaceuticals received FDA approval for a new generic drug formulation (ANDA090431) on December 28, 2010, positionin...
Amneal
FDA Approves OXYMORPHONE HYDROCHLORIDE — Amneal Pharmaceuticals of New York LLC
# FDA Approves Amneal Pharmaceuticals' Generic Oxymorphone Hydrochloride Amneal Pharmaceuticals of New York LLC received FDA approval for its generic...
GENUS
FDA Approves Unknown Drug — GENUS LIFESCIENCES
GENUS LIFESCIENCES received U.S. approval on Oct. 20 for NDA200534, a drug application; this regulatory milestone positions the company to potentially...
Genus
FDA Approves OXYCODONE HYDROCHLORIDE — Genus Lifesciences Inc.
Genus Lifesciences Inc. received FDA approval on October 20, 2010, for OxyCODONE HYDROCHLORIDE (NDA200535), a move expected to bolster the generic mar...
Strides
FDA Approves LOSARTAN POTASSIUM 25 MG — Strides Pharma Science Limited
# FDA Approves Strides Pharma's Generic Losartan Potassium Tablet Strides Pharma Science Limited received FDA approval for its generic losartan potas...
Lupin
FDA Approves LOSARTAN POTASSIUM — Lupin Pharmaceuticals, Inc.
# FDA Approves Lupin Pharmaceuticals' Generic Losartan Potassium Lupin Pharmaceuticals, Inc. received FDA approval for its generic losartan potassium...
Hikma
FDA Approves OXYMORPHONE HYDROCHLORIDE — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. secured FDA approval to manufacture the generic form of Oxymorphone Hydrochloride, an oral analgesic, providing a cost-...
PAI
FDA Approves BUPRENORPHINE HYDROCHLORIDE — PAI Holdings, LLC dba PAI Pharma
PAI Holdings, LLC has received FDA approval for its ANDA for buprenorphine hydrochloride, solidifying its position in the critical opioid addiction tr...
Merz
FDA Approves XEOMIN — Merz Pharmaceuticals, LLC
On July 30, 2010, Merz Pharmaceuticals, LLC received FDA approval for XEOMIN (incobotulinumtoxin A), signaling a new entrant in the botulinum toxin ty...
Knoa
FDA Approves BUTRANS — Knoa Pharma LLC
Knoa Pharma LLC secured FDA approval for its BUTRANS transdermal patch, expanding the market for long-acting opioid delivery systems in the chronic pa...
ANI
FDA Approves Unknown Drug — ANI PHARMS
Moments ago, ANI PHARMS announced FDA approval for its generic version of the unnamed substance, expected to broaden the company’s revenue streams and...
Strides
FDA Approves MYCOPHENOLATE MOFETIL — Strides Pharma Science Limited
Strides Pharma Science Limited announced the successful launch of oral Mycophenolate Mofetil (ANDA090055) to compete in this critical cardiovascular m...