FDA Approves RISEDRONATE SODIUM — Aurobindo Pharma Limited
Aurobindo Pharma received FDA approval for its generic Risedronate Sodium oral tablets, opening a new revenue opportunity within the osteoporosis market. This clearance allows the …
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Aurobindo Pharma received FDA approval for its generic Risedronate Sodium oral tablets, opening a new revenue opportunity within the osteoporosis market. This clearance allows the …
BioDelivery Sciences International Inc. announced the FDA approval of BELBUCA, a buccal film intended for the management of moderate to severe chronic pain that positions the compa…
# FDA Approves WG Critical Care's Dexmedetomidine Injection for Intravenous Use WG Critical Care, LLC has received FDA approval for its intravenous dexmedetomidine hydrochloride f…
# FDA Approves Apotex's Generic Ibandronate Sodium Injection Apotex Corp. received FDA approval for its generic ibandronate sodium intravenous formulation, expanding the competiti…
# FDA Approves Aurolife Pharma's Generic Methadone Hydrochloride Aurolife Pharma, LLC has received FDA approval for its generic methadone hydrochloride oral formulation, expanding…
On August 18, 2015, Epic Pharma, LLC received approval for ANDA090065 to manufacture generic methadone hydrochloride tablets, a move expected to intensify competitive pressure on b…
# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for ORKAMBI (lumacaftor and ivacaftor), marking a sign…
# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC has received FDA approval for its generic desoximetasone topical fo…
Xiromed LLC secured FDA approval for JAIMIESS, the generic version of Levonorgestrel and Ethinyl Estradiol tablets, positioning the company to capture market share in the hormonal …
Cranbury Pharmaceuticals, LLC secured FDA approval for its generic Morphine Sulfate oral formulation, granting the company a strategic foothold in the competitive generic opioid ma…
Lupin Pharmaceuticals, Inc. received FDA approval for its Abbreviated New Drug Application #ANDA204603 to manufacture Oxycodone Hydrochloride on April 29, 2015, impacting the marke…
Sanofi has announced that its subsidiary, Actavis Elizabeth, has received final approval from the FDA for its generic drug, which is expected to竞争扩大该产品线的市场份额并支撑公司近期在仿制药领域的强劲增长势头.
Novartis Pharmaceuticals received FDA approval for Secukinumab (Cosentyx) on Jan. 21, 2015, a strategic milestone expected to bolster the company’s portfolio in the autoimmune ther…
Zydus Pharmaceuticals USA Inc. secured FDA approval for Carbidopa and Levodopa, providing a new oral generic option into the high-volume central nervous system (CNS) market. This a…
Teva Pharmaceutical received FDA approval for its Abbreviated New Drug Application (ANDA 202718) on December 29, 2014, enabling the generic launch of an unnamed drug candidate. Thi…
The FDA has approved Opdivo (nivolumab) from E.R. Squibb & Sons, L.L.C., a key asset for the manufacturer's oncology franchise that is poised to bolster market share within the exp…
Carwin Pharmaceutical Associates, LLC received FDA clearance for its potassium chloride oral formulation POKONZA, a move expected to expand generic supply and increase market compe…
# FDA Approves Merck's ZERBAXA (Ceftolozane and Tazobactam) for Serious Bacterial Infections The FDA has approved Merck Sharp & Dohme LLC's ZERBAXA (ceftolozane and tazobactam), a…
PH HEALTH has attained FDA approval under ANDA203573, a milestone finalized on December 18 that is anticipated to drive commercial growth and solidify the company's competitive sta…
# FDA Approves Fonseca Biosciences' XTORO for Ear Infections The FDA has approved Fonseca Biosciences' XTORO (finafloxacin), an otic fluoroquinolone antibiotic for auricular admin…