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On June 14, 2018, Mylan Pharmaceuticals Inc. received FDA approval to launch Buprenorphine and Naloxone tablets, bringing a potent generic alternative...
Eli Lilly and Company’s FDA approval of the oral rheumatoid arthritis medication OLUMIANT (baricitinib) is expected to bolster the company’s market sh...
Sun Pharmaceutical Industries received FDA approval for its generic oral formulation of abiraterone acetate (NDA 210308) on May 22, 2018. The entry of...
SpecGx LLC announced FDA approval for its abuse-deterrent oxycodone hydrochloride tablets, positioning the company to compete for a slice of the gener...
# FDA Approves Generic Methylprednisolone Oral Formulation from Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for its gener...
# FDA Approves Kyowa Kirin's CRYSVITA for X-Linked Hypophosphatemia Treatment Kyowa Kirin, Inc. received FDA approval for CRYSVITA (burosumab), a fir...
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 ...
Epic Pharma, LLC has obtained FDA approval for ANDA 203863 to manufacture hydrocodone bitartrate and acetaminophen, broadening the generic availabilit...
Rhodes Pharmaceuticals announced today that the FDA has granted approval for ANDA 207808, which, pending market entry, will allow the company to capit...
XIROMED announced today the approval by the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA202970), signaling a ...
Eywa Pharma Inc. has received final FDA approval for its ANDA 207510, allowing for the generic sale of the opioid combination oxycodone and acetaminop...
On February 27, 2018, Zydus Pharma received FDA approval for ANDA206798, signaling a significant opportunity to capture market share in the undetermin...
# FDA Approves Janssen's ERLEADA for Prostate Cancer Treatment Janssen Products, LP received FDA approval for ERLEADA (apalutamide), an oral androgen...
Gilead Sciences, Inc. announced the approval of BIKTARVY (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate), a fully-supply single-tabl...
Strides Pharma Science Limited’s approval for the generic NSAID Piroxicam adds a new competitor to the US market, likely increasing pricing pressure o...
# FDA Approves Generic Drug Application for Amneal Pharmaceuticals Amneal Pharmaceuticals received FDA approval for ANDA210040 on December 22, 2017, ...
On December 20, 2017, the FDA approved macimorelin (Macrilen), developed by Aeterna Zentaris GmbH, marking a significant milestone as the first endoge...
# FDA Approves Merck's STEGLUJAN Combination Therapy for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLUJAN (ertugliflozin a...
# FDA Approves Merck's STEGLATRO (Ertugliflozin) for Type 2 Diabetes Merck Sharp & Dohme LLC received FDA approval for STEGLATRO (ertugliflozin), an ...
# FDA Approves Generic Zoledronic Acid Intravenous Formulation Eugia US LLC has received FDA approval for its generic zoledronic acid intravenous for...