FDA Approves IBANDRONATE SODIUM — Bionpharma Inc.
# FDA Approves Generic Ibandronate Sodium from Bionpharma Inc. Bionpharma Inc. has received FDA approval for its generic ibandronate sodium oral formulation, expanding treatment o…
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# FDA Approves Generic Ibandronate Sodium from Bionpharma Inc. Bionpharma Inc. has received FDA approval for its generic ibandronate sodium oral formulation, expanding treatment o…
# FDA Approves ANDA for PHARMOBEDIENT PHARMOBEDIENT has received FDA approval for ANDA078995, marking the company's entry into an additional generic drug market and expanding its …
# FDA Approves Hope Pharmaceuticals' Sodium Thiosulfate Injection Hope Pharmaceuticals received FDA approval for sodium thiosulfate intravenous injection on February 14, 2012, mar…
# FDA Approves Vertex Pharmaceuticals' KALYDECO for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for KALYDECO (ivacaftor), an oral medication represen…
GENUS Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA 200343), a development poised to bolster the manufacturer's market position and revenue p…
# FDA Approves Mayne Pharma's Generic Isotretinoin Mayne Pharma received FDA approval for its generic isotretinoin oral formulation (ANDA076485) on January 19, 2012, marking anoth…
Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous ARGATROBAN application in January 2012, broadening its product portfolio of anticoagulants and strengthenin…
Alvogen, Inc. announced FDA approval for its Abbreviated New Drug Application (ANDA202116) to manufacture generic oxycodone hydrochloride tablets, signaling the company’s strategic…
Sun Pharmaceutical Industries, Inc. has received FDA approval for its Abbreviated New Drug Application for the oral formulation of TRAMADOL HYDROCHLORIDE, positioning the company t…
# FDA Approves ANDA for Strides Pharma Strides Pharma has received FDA approval for ANDA 202075, expanding its generic drug portfolio and positioning the company to capture market…
# FDA Approves Fresenius Kabi's Generic Meropenem Injectable Fresenius Kabi USA, LLC received FDA approval for its generic meropenem intravenous formulation, expanding the competi…
Unichem Pharmaceuticals (USA), Inc. announced the FDA approval of its oral LAMOTRIGINE generic formulation, a milestone that positions the company to compete for market share withi…
Sagent Pharmaceuticals has received FDA approval for the generic intramuscular injection of clindamycin phosphate, expanding its portfolio of branded generics. This approval streng…
# FDA Approves SpecGx LLC's Generic Morphine Sulfate Oral Formulation SpecGx LLC has received FDA approval for its generic morphine sulfate oral formulation (ANDA202348), expandin…
# FDA Approves Janssen Pharmaceuticals' XARELTO (Rivaroxaban) Oral Anticoagulant Janssen Pharmaceuticals, Inc. received FDA approval for XARELTO (rivaroxaban), an oral anticoagula…
The FDA’s approval of a generic pharmaceutical from SANDOZ is poised to strengthen the company’s market presence and drive revenue growth, however, the specific therapeutics involv…
On March 22, 2011, Actavis Labs Fl Inc received FDA approval for ANDA090084, a generic drug anticipated to drive incremental sales in the specific therapeutic market while offering…
# FDA Approves Bayer's Gadavist (Gadobutrol) for MRI Contrast Imaging Bayer HealthCare Pharmaceuticals Inc. received FDA approval for Gadavist (gadobutrol), an intravenous contras…
Teva Pharmaceutical Industries received FDA approval on Thursday for Nifedipine Extended Release Tablets, extending its reach within the cardiovascular generic market.
SpecGx LLC announced the FDA approval of the Fentanyl Transdermal ANDA (App # ANDA077154) on February 9th, potentially expanding generic competition for the potent opioid pain patc…