Amphastar Pharmaceuticals, Inc.
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Latest From Amphastar Pharmaceuticals, Inc.
US FDA Calls ’Em Like Its Advisory Committees See Them
So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.
New Oncologics Overwhelmingly Approved In US Before EU
Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.
Three Gene Therapies, Moderna Metabolic Drug In Inaugural START Class; CBER Oversubscribes
Seven rare disease programs make up the first round of participants in the US FDA’s ‘Operation Warp Speed’-style program. Sponsors will benefit from ‘rapid, ad hoc’ communication with the agency.
Amphastar Plans To Launch Second OTC Product Also In Emergency Medicine Category
Amphastar plans in 2024 to submit application to FDA to move its Rextovy 4mg naloxone hydrochloride intranasal formulation from Rx to OTC. Advertising to drive Primatene Mist awareness planned.
Company Information
- Industry
- Pharmaceuticals
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Pharmaceuticals
- Drug Delivery
- Generic Drugs
- OTC, Consumer
- Specialty Pharmaceuticals
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Drug Delivery
- Nasal
- Pulmonary
- Other Names / Subsidiaries
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- Amphastar France Pharmaceuticals (AFP)
- Armstrong Pharmaceuticals, Inc.
- International Medication Systems (IMS)
- Nanjing Puyan Pharmaceutical Technology (ANP)
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