FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception : Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. FDA Emergency Use Authorization Statement.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. IMPORTANT SAFETY INFORMATION. Disclosure Notice.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. 5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. Pfizer’s total global revenue from Paxlovid was $18.93 billion in 2022.

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Sales Manufacturing FDA Approval Life Science 98