Genentech,
FDA Approves HERCEPTIN HYLECTA — Genentech, Inc.
Genentech, Inc. received FDA approval for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) in early 2019, a formulation designed to significantl...
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Rising
FDA Approves ABIRATERONE ACETATE — Rising Pharma Holdings, Inc.
Rising Pharma Holdings, Inc. announced the FDA’s February 25, 2019, approval of its oral Abiraterone Acetate drug, positioning the company to compete ...
HIBROW
FDA Approves Unknown Drug — HIBROW HLTHCARE
# FDA Approves ANDA for Hibrow Healthcare Hibrow Healthcare received FDA approval for an abbreviated new drug application (ANDA207863) on February 4,...
Organon
FDA Approves ONTRUZANT — Organon LLC
# FDA Approves Organon's ONTRUZANT (Trastuzumab) Biosimilar The FDA has approved Organon LLC's ONTRUZANT (trastuzumab), a biosimilar to Herceptin, ma...
CONCORD
FDA Approves MYCOPHENOLATE MOFETIL — CONCORD BIOTECH LIMITED
Concord Biotech Limited announced Thursday that its generic application (ANDA 210181) for Mycophenolate Mofetil – used to prevent organ transplant rej...
Amneal
FDA Approves LURASIDONE HYDROCHLORIDE — Amneal Pharmaceuticals LLC
# Amneal Pharmaceuticals Receives FDA Approval for Generic Lurasidone Hydrochloride Amneal Pharmaceuticals LLC has received FDA approval for its gene...
Camber
FDA Approves METHADONE HYDROCHLORIDE — Camber Pharmaceuticals, Inc
Camber Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application of Methadone Hydrochloride, positioning the company to enter ...
Torrent
FDA Approves LURASIDONE HYDROCHLORIDE — Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals Limited has received FDA approval for its ANDA for Lurasidone Hydrochloride Oral, supporting the firm's broadening generic pha...
Alexion
FDA Approves ULTOMIRIS — Alexion Pharmaceuticals Inc.
# FDA Approves Alexion Pharmaceuticals' ULTOMIRIS for Complement-Mediated Disorders Alexion Pharmaceuticals Inc. received FDA approval for ULTOMIRIS ...
Merz
FDA Approves INBRIJA — Merz Pharmaceuticals, LLC
# FDA Approves Merz Pharmaceuticals' INBRIJA (Levodopa Inhalation Powder) for Parkinson's Disease Merz Pharmaceuticals has received FDA approval for ...
IBSA
FDA Approves LICART — IBSA Pharma Inc.
IBSA Pharma Inc. secured FDA approval for its topical arthritis drug LICART in December 2018, expanding its product portfolio and increasing market sh...
NorthStar
FDA Approves HEPARIN SODIUM — NorthStar RxLLC
# FDA Approves NorthStar Medical Systems' Heparin Sodium Injectable The FDA has approved NorthStar Medical Systems' abbreviated new drug application ...
ACERTIS
FDA Approves LEVORPHANOL TARTRATE — ACERTIS PHARMACEUTICALS, LLC
ACERTIS PHARMACEUTICS announced Friday that FDA approval of its generic version of oral levorphanol tartrate could expose the company to volume-depend...
Ferring
FDA Approves FYREMADEL — Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. announced the FDA approval of its ANDA for Ganirelix Acetate, positioning the company to capitalize on the expiration of ...
Granules
FDA Approves METHYLPHENIDATE HYDROCHLORIDE — Granules Pharmaceuticals Inc.
Granules Pharmaceuticals Inc. secured FDA approval for its Abbreviated New Drug Application of methylphenidate hydrochloride tablets, unlocking a sign...
Glenmark
FDA Approves ATOVAQUONE — Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc. secured FDA approval for generic atovaquone, enabling the firm to compete in the established antiparasitic market. This ...
Elite
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Elite Laboratories, Inc.
# FDA Approves Elite Laboratories' Generic Hydrocodone Bitartrate and Acetaminophen Elite Laboratories, Inc. received FDA approval for its generic fo...
Zydus
FDA Approves ARSENIC TRIOXIDE — Zydus Pharmaceuticals USA Inc.
# FDA Approves Arsenic Trioxide Generic from Zydus Pharmaceuticals The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic arsenic trioxide int...
ALVOGEN
FDA Approves Unknown Drug — ALVOGEN
ALVOGEN announced on November 8, 2018, the approval of its Abbreviated New Drug Application (ANDA208540), signaling the company's strategic expansion ...
Camber
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Camber Pharmaceuticals, Inc.
Camber Pharmaceuticals, Inc. received FDA approval for Abbreviated New Drug Application #211487 covering hydrocodone bitartrate and acetaminophen oral...