FDA Approves Unknown Drug — APOTEX INC
Apotex Inc. received FDA approval for Abbreviated New Drug Application (ANDA) #091308, signaling its entry into the market with a generic alternative that is anticipated to increas…
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Apotex Inc. received FDA approval for Abbreviated New Drug Application (ANDA) #091308, signaling its entry into the market with a generic alternative that is anticipated to increas…
# FDA Approves Teva's Generic Irbesartan and Hydrochlorothiazide Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic version of the irbesartan and hydro…
ALKEM LABS LTD secured an FDA approval for ANDA202076, a regulatory milestone expected to bolster the company's market presence and unlock significant commercial potential for its …
On March 28, 2012, Northstar Rx LLC won FDA approval of its ANDA for the combined oral contraceptive ELINEST (norgestrel and ethinyl estradiol), positioning the manufacturer to com…
# 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…
Merck Sharp & Dohme has received FDA approval for JANUMET XR, merging sitagliptin and metformin into an once-daily formulation expected to heighten market rivalry and streamline tr…
# 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…
Strides Pharma International announced this week that its Abbreviated New Drug Application No. ANDA200812 had been approved by the FDA, paving the way for the introduction of a new…
# 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…