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# FDA Approves Unichem Pharmaceuticals' Generic Tramadol Hydrochloride Unichem Pharmaceuticals (USA), Inc. received FDA approval for its generic tramadol hydrochloride oral formul…
# FDA Approves Generic Celecoxib Application for AiPing Pharmaceutical The FDA has approved ANDA208856 for AiPing Pharmaceutical, Inc.'s generic celecoxib oral formulation, markin…
# FDA Approves New Generic Drug Application for Hibrow Healthcare Hibrow Healthcare has received FDA approval for its abbreviated new drug application (ANDA 207611), positioning t…
Cordavis Limited announced the FDA approval of adalimumab-bwwd, a biosimilar of a major TNF-alpha inhibitor, allowing for the establishment of a new manufacturing platform designed…
Upsher-Smith Laboratories, LLC announced the approval of a supplemental New Drug Application for its Morphine Sulfate product, broadening its portfolio of FDA-approved opioid treat…
# FDA Approves Karyopharm Therapeutics' XPOVIO (selinexor) for Multiple Myeloma Karyopharm Therapeutics Inc. received FDA approval for XPOVIO (selinexor), an oral selective inhibi…
Advagen Pharma Limited has gained FDA approval for its oral Tramadol Hydrochloride tablets, granting the company entry into the generic market for a widely prescribed analgesic and…
Eywa Pharma Inc. received 180-day exclusivity for the ANDA211610 approval of acetaminophen and codeine phosphate oral dosage form on June 27, 2019, signaling heighted competitive p…
Mylan received FDA approval on June 19, 2019, for the generic transdermal formulation of scopolamine, signaling a significant opportunity for market expansion into the motion-sickn…
# FDA Approves Genentech's POLIVY (polatuzumab vedotin) for Intravenous Administration Genentech's FDA approval of POLIVY (polatuzumab vedotin) marks the company's entry into the …
# FDA Approves Generic Bosentan The FDA has approved Actavis Pharma, Inc.'s generic formulation of bosentan (ANDA207110), a pulmonary arterial hypertension treatment, potentially …
# FDA Approves Generic Bosentan The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic formulation of bosentan, an endothelin receptor antagonist used to treat pulmonary ar…
# FDA Approves AbbVie's SKYRIZI for Psoriasis Treatment AbbVie Inc. received FDA approval for SKYRIZI (risankizumab-rzaa), a subcutaneous IL-23 inhibitor, positioning the company …
SpecGx LLC today received FDA approval for its generic version of the ADHD drug Mixed Salts of a Single Entity Amphetamine Product XR, an event that signals increased competition i…
Dr. Reddy’s Laboratories received FDA approval for its testosterone transdermal generic, a move that positions the company to expand its market share in the competitive hormone rep…
On March 26, 2019, the U.S. FDA granted approval to Novartis Pharmaceuticals for Mayzent (siponimod), offering a new oral treatment option for adult patients with active multiple s…
Eywa Pharma Inc. has obtained FDA approval for its generic hydrocodone bitartrate and acetaminophen oral tablets, a regulatory milestone expected to bolster the company's market pr…
Genentech, Inc. received FDA approval for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) in early 2019, a formulation designed to significantly improve the convenience and …
Rising Pharma Holdings, Inc. announced the FDA’s February 25, 2019, approval of its oral Abiraterone Acetate drug, positioning the company to compete within the androgen signaling …
# FDA Approves ANDA for Hibrow Healthcare Hibrow Healthcare received FDA approval for an abbreviated new drug application (ANDA207863) on February 4, 2019, expanding its generic d…