FDA Approves Unknown Drug — STRIDES PHARMA
1. **Analyze the Request:** * **Topic:** FDA drug approval. * **Input Data:** * Brand: N/A * Generic: N/A * Substance: [Missing from prom…
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1. **Analyze the Request:** * **Topic:** FDA drug approval. * **Input Data:** * Brand: N/A * Generic: N/A * Substance: [Missing from prom…
Lannett Co. Inc. has received FDA approval for ANDA 207171, which is expected to bolster its generic portfolio and contribute incremental revenue as the product enters the market.
Lupin Pharmaceuticals, Inc. received FDA approval for its Oxycodone Hydrochloride generic on June 12, 2017, securing a position in the competitive opioid market and positioning the…
# FDA Approves Generic Drug Application for Sagent Pharmaceuticals Sagent Pharmaceuticals Inc. received FDA approval for ANDA 203608 on May 11, 2017, expanding its generic drug po…
FDA approved KVK-TECH, Inc.’s abbreviated new drug application (ANDA) for methylphenidate hydrochloride, ramping up generic competition for the ADHD treatment. The approval is expe…
Novartis has secured FDA approval for the co-packaged fixed-dose combination of KISQALI and Femara (ribociclib and letrozole), a strategic move aimed at improving medication adhere…
# FDA Approves AstraZeneca's IMFINZI (Durvalumab) for Cancer Treatment AstraZeneca Pharmaceuticals LP has received FDA approval for IMFINZI (durvalumab), an intravenous immunother…
# FDA Approves Rising's Generic Drug Application The FDA approved ANDA200542 for Rising Pharmaceuticals on April 28, 2017, expanding the company's generic drug portfolio and posit…
On April 28, the FDA approved a generic version of the nasal spray AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE manufactured by Apotex Corp., representing significant market…
# FDA Approves Azurity Pharmaceuticals' XATMEP Oral Methotrexate Formulation Azurity Pharmaceuticals has received FDA approval for XATMEP (methotrexate), an oral formulation of th…
Protega Pharmaceuticals Inc. has received FDA approval for Roxycbond (oxycodone hydrochloride), a crucial strategic addition for the company intended to bolster its market portfoli…
# FDA Approves Piroxicam Generic for Unichem Pharmaceuticals Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic piroxicam oral formulation, expanding the co…
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for an abbreviated new drug application (ANDA 207367), expanding i…
# FDA Approves Rising Pharmaceuticals' Generic Drug Application Rising Pharmaceuticals has received FDA approval for ANDA200217, expanding its generic drug portfolio and positioni…
# FDA Approves Genentech's OCREVUS for Multiple Sclerosis Treatment Genentech announced FDA approval of OCREVUS (ocrelizumab), an intravenous monoclonal antibody therapy, position…
Camber Pharmaceuticals gained FDA approval for its ANDA207419 formulation of oxycodone and acetaminophen tablets, granting the company the rights to supply a lower-cost alternative…
The FDA has granted approval to Aurobindo Pharma Limited for its generic Tramadol Hydrochloride oral product, marking a new competitive entry into the opioid analgesic market. This…
# FDA Approves Generic Oxaliplatin from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for a generic version of oxaliplatin, an intravenous chemotherapy drug,…
On March 21, 2017, Ascend Laboratories, LLC received FDA approval for the ANDA for rosuvastatin calcium, a generic version of the widely used cholesterol-lowering drug. This route-…
TEVA PHARMS USA reported the approval of its Abbreviated New Drug Application (ANDA 205807) on March 10, 2017, a milestone that positions the company to enter the generic market fo…