FDA Approves NUZYRA — Paratek Pharmaceuticals, Inc.
On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps caused by the rising threat of drug…
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On October 2, 2018, Paratek Pharmaceuticals received FDA approval for NUZYRA (omadacycline), an oral antibiotic poised to address treatment gaps caused by the rising threat of drug…
Teva Pharmaceuticals USA, Inc. announced FDA approval for Fremanezumab subcutaneously, a move poised to intensify competitive pricing in the migraine market and expand the company’…
Breckenridge Pharmaceuticals has secured FDA approval for ANDA 208283 regarding oral eplerenone, introducing an additional generic option that is expected to heighten market compet…
BioCodex's FDA approval of oral Diacomit allows the manufacturer to enter the epilepsy market with its stiripentol-based treatment, potentially driving new revenue streams and disr…
BioCodex, Inc. secured FDA clearance for Diacomit to treat refractory pediatric epileptic encephalopathies, allowing the company to capitalize on the specialized neurology market. …
# FDA Approves Generic Fexofenadine Hydrochloride for Pioneer Life Sciences Pioneer Life Sciences, LLC received FDA approval for its generic fexofenadine hydrochloride oral formul…
# FDA Approves Kyowa Kirin's POTELIGEO for Cutaneous T-Cell Lymphoma Treatment The FDA has approved Kyowa Kirin, Inc.'s POTELIGEO (mogamulizumab-kpkc), an intravenous monoclonal a…
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Treatment Vertex Pharmaceuticals Incorporated announced FDA approval of ORKAMBI (lumacaftor and ivacaftor) on Au…
FDA approval of Indivior Inc.'s PERSERIS, a risperidone implant, expands the company's market footprint within the long-acting antipsychotic sector, introducing a strategic alterna…
# FDA Approves Sagent Pharmaceuticals' Generic Gemcitabine Injection Sagent Pharmaceuticals has received FDA approval for its generic gemcitabine hydrochloride intravenous formula…
# FDA Approves Generic Dalfampridine from Accord Healthcare Accord Healthcare Inc. received FDA approval for the generic version of dalfampridine, an oral treatment for multiple s…
Jazz Pharmaceuticals, Inc. secured a significant market foothold following the FDA approval of oral cannabidiol drug Epidiolex, positioning the biotech giant to generate substantia…
Upsher-Smith Laboratories secured FDA approval for its generic Vigabatrin (VIGADRONE) oral formulation on June 21, 2018, via ANDA 210196 to capitalize on a growing market of cost-c…
# FDA Approves Slate Run Pharmaceuticals' Generic Bupropion HCl XL Slate Run Pharmaceuticals, LLC has received FDA approval for its generic formulation of bupropion hydrochloride …
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its buccal Buprenorphine and Naloxone tablets, expanding its portfolio in the opioid dependence market with a potentiall…
Eli Lilly and Company’s FDA approval of the oral rheumatoid arthritis medication OLUMIANT (baricitinib) is expected to bolster the company’s market share in the competitive JAK inh…
SpecGx LLC announced FDA approval for its abuse-deterrent oxycodone hydrochloride tablets, positioning the company to compete for a slice of the generic opioid market share.
# FDA Approves Generic Methylprednisolone Oral Formulation from Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for its generic methylprednisolone oral for…
# FDA Approves Kyowa Kirin's CRYSVITA for X-Linked Hypophosphatemia Treatment Kyowa Kirin, Inc. received FDA approval for CRYSVITA (burosumab), a first-in-class subcutaneous thera…
ANI PHARMS secured an FDA approval for ANDA 205509, signaling a key entry into the market with commercial potential expected to bolster the company's revenue streams in the generic…