FDA Approves VIGADRONE — Upsher-Smith Laboratories, LLC
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…
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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…
Epic Pharma, LLC has obtained FDA approval for ANDA 203863 to manufacture hydrocodone bitartrate and acetaminophen, broadening the generic availability of this widely prescribed pa…
Rhodes Pharmaceuticals announced today that the FDA has granted approval for ANDA 207808, which, pending market entry, will allow the company to capitalize on generic demand for th…
XIROMED announced today the approval by the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA202970), signaling a strategic expansion into a new…
Eywa Pharma Inc. has received final FDA approval for its ANDA 207510, allowing for the generic sale of the opioid combination oxycodone and acetaminophen by March 21, 2018. The inc…
On February 27, 2018, Zydus Pharma received FDA approval for ANDA206798, signaling a significant opportunity to capture market share in the undetermined therapeutic segment followi…
# FDA Approves Janssen's ERLEADA for Prostate Cancer Treatment Janssen Products, LP received FDA approval for ERLEADA (apalutamide), an oral androgen receptor inhibitor for prosta…
Gilead Sciences, Inc. announced the approval of BIKTARVY (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate), a fully-supply single-tablet regimen that significantly …
Strides Pharma Science Limited’s approval for the generic NSAID Piroxicam adds a new competitor to the US market, likely increasing pricing pressure on branded versions. This devel…
# FDA Approves Generic Drug Application for Amneal Pharmaceuticals Amneal Pharmaceuticals received FDA approval for ANDA210040 on December 22, 2017, expanding its generic pharmace…
On December 20, 2017, the FDA approved macimorelin (Macrilen), developed by Aeterna Zentaris GmbH, marking a significant milestone as the first endogenous ghrelin mimetic treatment…
# FDA Approves Merck's STEGLUJAN Combination Therapy for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLUJAN (ertugliflozin and sitagliptin), a dual-mechan…
# FDA Approves Merck's STEGLATRO (Ertugliflozin) for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLATRO (ertugliflozin), an oral SGLT2 inhibitor, position…