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 under the brand XYZAL ALLERGY …
SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.
# 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…
# 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…
Sun Pharmaceutical Industries secured FDA approval for a generic medication under ANDA205634, a development expected to strengthen the company’s competitive positioning and drive f…
# FDA Approves Sanofi-Aventis Biologic Drug The U.S. Food and Drug Administration has approved a new biologic drug from Sanofi-Aventis US (BLA208471), potentially strengthening th…
Trigen Laboratories, LLC announced the FDA approval of its ANDA for oral hydromorphone hydrochloride tablets, adding a new generic entrant to the strong opioid analgesic market. Th…
Stride Pharma International announced approval of its Abbreviated New Drug Application (ANDA) on July 5, 2016, indicating regulatory clearance to enter the market, though specific …
Strides Pharma Science Limited announced the FDA approval of its generic Hydrocodone Bitartrate and Acetaminophen products, a move anticipated to invite immediate price competition…
# FDA Approves Generic Irbesartan from Hisun Pharmaceuticals USA Inc. The FDA has approved Hisun Pharmaceuticals USA Inc.'s generic formulation of irbesartan, an oral antihyperten…
# FDA Approves Generic Hydrocodone Bitartrate and Ibuprofen Combination Aurolife Pharma, LLC has received FDA approval for a generic version of the hydrocodone bitartrate and ibup…
Actavis Labs Florida, Inc. secured FDA approval for its generic sildenafil citrate tablets (20 mg), clearing the way for a competitive launch in the Pulmonary Arterial Hypertension…
The FDA has approved a supplementary ANDA for oral atorvastatin calcium by Cipla USA Inc., allowing the company to expand its generic cholesterol-lowering offerings. This clearance…
# FDA Approves Genentech's TECENTRIQ (atezolizumab) for Bladder Cancer Genentech, Inc. received FDA approval for TECENTRIQ (atezolizumab), a PD-L1 inhibitor administered intraveno…