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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…
# FDA Approves Organon's ONTRUZANT (Trastuzumab) Biosimilar The FDA has approved Organon LLC's ONTRUZANT (trastuzumab), a biosimilar to Herceptin, marking another competitive entr…
# Amneal Pharmaceuticals Receives FDA Approval for Generic Lurasidone Hydrochloride Amneal Pharmaceuticals LLC has received FDA approval for its generic oral formulation of lurasi…
Camber Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application of Methadone Hydrochloride, positioning the company to enter the critical market for opioid…
Torrent Pharmaceuticals Limited has received FDA approval for its ANDA for Lurasidone Hydrochloride Oral, supporting the firm's broadening generic pharmaceutical portfolio. This en…
# FDA Approves Alexion Pharmaceuticals' ULTOMIRIS for Complement-Mediated Disorders Alexion Pharmaceuticals Inc. received FDA approval for ULTOMIRIS (ravulizumab), an intravenous …
# FDA Approves Merz Pharmaceuticals' INBRIJA (Levodopa Inhalation Powder) for Parkinson's Disease Merz Pharmaceuticals has received FDA approval for INBRIJA, a novel inhaled formu…
IBSA Pharma Inc. secured FDA approval for its topical arthritis drug LICART in December 2018, expanding its product portfolio and increasing market share within the legal-medicine …
# FDA Approves NorthStar Medical Systems' Heparin Sodium Injectable The FDA has approved NorthStar Medical Systems' abbreviated new drug application (ANDA 211005) for heparin sodi…
ACERTIS PHARMACEUTICS announced Friday that FDA approval of its generic version of oral levorphanol tartrate could expose the company to volume-dependent sales and delayed competit…
Ferring Pharmaceuticals Inc. announced the FDA approval of its ANDA for Ganirelix Acetate, positioning the company to capitalize on the expiration of FYREMADEL exclusivity and secu…
Granules Pharmaceuticals Inc. secured FDA approval for its Abbreviated New Drug Application of methylphenidate hydrochloride tablets, unlocking a significant revenue opportunity in…
Glenmark Pharmaceuticals Inc. secured FDA approval for generic atovaquone, enabling the firm to compete in the established antiparasitic market. This approval broadens Glenmark's p…
# FDA Approves Elite Laboratories' Generic Hydrocodone Bitartrate and Acetaminophen Elite Laboratories, Inc. received FDA approval for its generic formulation of hydrocodone bitar…