RISING
FDA Approves Unknown Drug — RISING
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for an abbreviated new drug applicat...
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RISING
FDA Approves Unknown Drug — RISING
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for ANDA200217, expanding its generi...
Genentech,
FDA Approves OCREVUS — Genentech, Inc.
# FDA Approves Genentech's OCREVUS for Multiple Sclerosis Treatment Genentech announced FDA approval of OCREVUS (ocrelizumab), an intravenous monoclo...
Camber
FDA Approves OXYCODONE AND ACETAMINOPHEN — Camber Pharmaceuticals, Inc.
Camber Pharmaceuticals gained FDA approval for its ANDA207419 formulation of oxycodone and acetaminophen tablets, granting the company the rights to s...
Aurobindo
FDA Approves TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN — Aurobindo Pharma Limited
The FDA has granted approval to Aurobindo Pharma Limited for its generic Tramadol Hydrochloride oral product, marking a new competitive entry into the...
Accord
FDA Approves OXALIPLATIN — Accord Healthcare Inc.
# FDA Approves Generic Oxaliplatin from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for a generic version of oxaliplatin, an ...
Ascend
FDA Approves ROSUVASTATIN CALCIUM — Ascend Laboratories, LLC
On March 21, 2017, Ascend Laboratories, LLC received FDA approval for the ANDA for rosuvastatin calcium, a generic version of the widely used choleste...
TEVA
FDA Approves Unknown Drug — TEVA PHARMS USA
TEVA PHARMS USA reported the approval of its Abbreviated New Drug Application (ANDA 205807) on March 10, 2017, a milestone that positions the company ...
AMNEAL
FDA Approves Unknown Drug — AMNEAL PHARMS
On February 28, 2017, Amneal Pharmaceuticals received approval for ANDA 204741, a development that positions the company in significant market trial r...
RISING
FDA Approves Unknown Drug — RISING
Rising has received final FDA approval for its Abbreviated New Drug Application (ANDA #204043), positioning itself for entry into the market once the ...
ASTRAZENECA
FDA Approves Unknown Drug — ASTRAZENECA AB
# FDA Approves AstraZeneca Drug, Expanding Treatment Options in Key Therapeutic Area The U.S. Food and Drug Administration has approved AstraZeneca A...
Lupin
FDA Approves OXYCODONE AND ACETAMINOPHEN — Lupin Pharmaceuticals,Inc.
**FDA Approves ANDA for Lupin’s Oxycodone and Acetaminophen Combination Product** On February 24, 2017, the FDA approved Lupin Pharmaceuticals' Abbre...
PLATINUM
FDA Approves Unknown Drug — PLATINUM
PLATINUM announced the FDA approval of their ANDA submission, though specific product details and market implications are unavailable. Without a defin...
Bausch
FDA Approves SILIQ — Bausch Health US LLC
Bausch Health US LLC secured FDA approval for the subcutaneous formulation of Brodalumab under the brand SILIQ, a move expected to significantly diver...
Chattem,
FDA Approves XYZAL ALLERGY 24HR — Chattem, Inc.
# FDA Approves Chattem's XYZAL ALLERGY 24HR for Over-the-Counter Use The FDA has approved Chattem, Inc.'s levocetirizine dihydrochloride formulation ...
Chattem,
FDA Approves CHILDRENS XYZAL ALLERGY — Chattem, Inc.
# FDA Approves Chattem's Children's Xyzal Allergy Formulation Chattem, Inc. received FDA approval for Children's Xyzal Allergy (levocetirizine dihydr...
Zydus
FDA Approves METHOTREXATE — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. received FDA approval for oral Methotrexate under ANDA207812, marking a potential new generic entry into a crowded mark...
Saptalis
FDA Approves DESOXIMETASONE — Saptalis Pharmaceuticals, LLC.
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC received FDA approval for its generic...
Biogen
FDA Approves SPINRAZA — Biogen Inc.
# FDA Approves Biogen's SPINRAZA for Spinal Muscular Atrophy, Opening Rare Disease Market Opportunity Biogen Inc. received FDA approval for SPINRAZA ...
Boehringer
FDA Approves SYNJARDY XR — Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim today announced the FDA approval of SYNJARDY XR Empagliflozin/Metformin Hydrochloride, an extended-release oral tablet designed t...