Drug Approval | August 29, 2022
USFDA completes inspection at Aurolife Pharma’s Raleigh unit
The unit has filed 2 Derma products and 1 MDI product.
The unit has filed 2 Derma products and 1 MDI product.
Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age
Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September
There are no data integrity (DI) observations.
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
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