Drug Approval | 28 August 2022
Cipla receives 6 observations from USFDA for Goa facility
There are no data integrity (DI) observations.
There are no data integrity (DI) observations.
Lutio has the potential to offer significant cost savings when available to UK patients.
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Therapy recently approved in Canada under the brand name KORSUVA
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The product will be manufactured at Lupin's facility in Goa, India.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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