FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid | FDA

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid | FDA

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October 15, 2020

• FDA Drug Safety Communication: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

Recent New and Generic Drug Approvals

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

October 15, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Pegasys BLA #103964	Peginterferon Alfa-2a	Syringe	SUPPL-5273	Hoffman-La Roche	Labeling	Approved
Pegasys BLA #103964	Peginterferon Alfa-2a	Syringe	SUPPL-5273	Hoffman-La Roche	Labeling	Approved
Pegasys BLA #103964	Peginterferon Alfa-2a	Vial; Subcutaneous	SUPPL-5273	Hoffman-La Roche	Labeling	Approved
Pegasys BLA #103964	Peginterferon Alfa-2a	Vial; Subcutaneous	SUPPL-5273	Hoffman-La Roche	Labeling	Approved

October 14, 2020

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-7	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-7	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-19	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-21	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-22	Istituto Bio Ita Spa	Labeling	Approved
Piperacillin and Tazobactam ANDA #065523	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	SUPPL-22	Istituto Bio Ita Spa	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-22	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-24	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-26	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-20	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-21	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-22	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-24	Lannett Co Inc	Labeling	Approved
Valproic Acid ANDA #077960	Valproic Acid	Syrup; Oral	SUPPL-26	Lannett Co Inc	Labeling	Approved
Keytruda BLA #125514	Pembrolizumab	Powder, For Injection Solution, Lyophilized Powder	SUPPL-85	Merck Sharp Dohme	Efficacy	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-6	Dr Reddys	Labeling	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-2	Dr Reddys	Labeling	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-5	Dr Reddys	Labeling	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-6	Dr Reddys	Labeling	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-2	Dr Reddys	Labeling	Approved
Pramipexole Dihydrochloride ANDA #203354	Pramipexole Dihydrochloride	Tablet, Extended Release; Oral	SUPPL-5	Dr Reddys	Labeling	Approved
Dimethyl Fumarate ANDA #210382	Dimethyl Fumarate	Capsule, Delayed Release; Oral	ORIG-1	Twi Pharms		Approved
Inmazeb BLA #761169	Atoltivimab; Odesivimab; Maftivimab	Solution; Injection	ORIG-1	Regeneron Pharmaceuticals	Type 1 - New Molecular Entity	Approved