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 related to the specified substa…
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On February 28, 2017, Amneal Pharmaceuticals received approval for ANDA 204741, a development that positions the company in significant market trial related to the specified substa…
Rising has received final FDA approval for its Abbreviated New Drug Application (ANDA #204043), positioning itself for entry into the market once the original product patent expire…
# FDA Approves AstraZeneca Drug, Expanding Treatment Options in Key Therapeutic Area The U.S. Food and Drug Administration has approved AstraZeneca AB's new drug application (NDA2…
**FDA Approves ANDA for Lupin’s Oxycodone and Acetaminophen Combination Product** On February 24, 2017, the FDA approved Lupin Pharmaceuticals' Abbreviated New Drug Application fo…
PLATINUM announced the FDA approval of their ANDA submission, though specific product details and market implications are unavailable. Without a defined Substance or Generic name, …
ZYDUS PHARMS has received FDA approval for an ANDA (ANDA206097), a move that strengthens its commercial portfolio and is expected to create a significant market opportunity for the…
Bausch Health US LLC secured FDA approval for the subcutaneous formulation of Brodalumab under the brand SILIQ, a move expected to significantly diversify its biologic portfolio an…
# FDA Approves Chattem's XYZAL ALLERGY 24HR for Over-the-Counter Use The FDA has approved Chattem, Inc.'s levocetirizine dihydrochloride formulation under the brand XYZAL ALLERGY …
# FDA Approves Chattem's Children's Xyzal Allergy Formulation Chattem, Inc. received FDA approval for Children's Xyzal Allergy (levocetirizine dihydrochloride) oral formulation on…
Zydus Pharmaceuticals USA Inc. received FDA approval for oral Methotrexate under ANDA207812, marking a potential new generic entry into a crowded market segment where increasing co…
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC received FDA approval for its generic desoximetasone topical formul…
# FDA Approves Biogen's SPINRAZA for Spinal Muscular Atrophy, Opening Rare Disease Market Opportunity Biogen Inc. received FDA approval for SPINRAZA (nusinersen), an intrathecal t…
Boehringer Ingelheim today announced the FDA approval of SYNJARDY XR Empagliflozin/Metformin Hydrochloride, an extended-release oral tablet designed to improve glycemic control in …
Macleods Pharmaceuticals has received final approval from the US FDA for its generic Metformin Hydrochloride tablet salts, a product identified by ANDA206955, which is anticipated …
# FDA Approves Sanofi's SOLIQUA 100/33, a Fixed-Dose Combination Insulin and GLP-1 Receptor Agonist Sanofi-Aventis U.S. LLC received FDA approval for SOLIQUA 100/33 (insulin glarg…
Unichem Pharmaceuticals (USA), Inc. received the long-awaited FDA approval Monday for its ANDA 207428, providing generic access to oral Sotalol Hydrochloride. This move positions U…
FDA has granted approval for an Abbreviated New Drug Application (ANDA) from PHARMOBEDIENT, marking a pivotal step into the market for the associated brand-name product. While spec…
# FDA Approves Janssen Biotech's Ustekinumab Intravenous Formulation Janssen Biotech, Inc. received FDA approval for an intravenous formulation of ustekinumab, expanding the immun…
Aiping Pharm Inc announced on August 26, 2016, that it received FDA approval for its ANDA #204754, granting the company authorization to commercialize a generic product in the Unit…
The FDA has granted final approval to Exelan Pharmaceuticals Inc. for its ANDA for bupropion hydrochloride, setting the stage for increased generic competition in this major antide…