NEWS FROM USA
505(b)2s in pipeline
Risperidone ER Microsphere (Luye Pharma): Luye Pharma announced NDA submission of Risperidone ER microsphere.
Leuprolide mesylate 6 months depot (Foresee Pharma): Foresee pharma announced NDA submission of Leuprolide mesylate ready to use 6 months depot formulation
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Tadalafil Tablets |
Apotex |
Cialis (Eli Lilly) |
N/A |
NDA Approvals
|
Approval Date |
Drug |
NDA Sponsor |
Brand Name |
Prescribing information |
|
29 Mar 2019 |
Aclidinium Bromide; Formoterol Fumarate Dihydrate Power |
Astrazeneca |
Duaklir Pressair |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
28 Mar 2019 |
Zydus |
Letairis (Gilead) |
Three |
|
|
28 Mar 2019 |
Watson |
|||
|
28 Mar 2019 |
Mylan |
|||
|
28 Mar 2019 |
Sun Pharm |
|||
|
28 Mar 2019 |
Perrigo |
Xyzal Allergy 24 HR (Sanofi) |
Two |
|
|
28 Mar 2019 |
Aurobindo Pharma |
N/A |
Three |
GENERIC PATENT LITIGATIONS
Tapentadol (Assertio Therapeutics): Assertio Therapeutics Announces Favorable NUCYNTA CAFC Patent Ruling.
Lenaliomide (Celgene v. Alvogen): Celgene Settles U.S. REVLIMID Patent Litigation with Alvogen.
NEWS FROM EUROPE
Tadalafil (Actavis v. ICOS): UK supreme court rules in favour of generics in Tadalafil patent case.
If you have any query/suggestion then please write us at pharmacaption@gmail.com
No comments:
Post a Comment