NEWS FROM USA
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Budesonide inhalation suspension |
Lupin |
Pulmicort Repsules (Astra Zeneca) |
$385.4 Million |
|
|
Solifenacin Succinate tablets |
Apotex |
Vesicare (Astellas) |
N/A |
NDA APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
23 May 2019 |
Alpelisib tablets |
Novartis |
Piqray |
505(b)2 APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
23 May 2019 |
Drospirenone 4mg tablets |
Exeltis (Insud Pharma) |
Slynd* |
|
|
20 May 2019 |
Fulvestrant injection# |
Fresenius Kabi |
N/A |
N/A |
*Difference between Yaz and Slynd
- Yaz contains combination of Drospirenone (3mg) and Ethinyl Estradiol (0.02mg), while Slynd contains only Drospirenone (4mg).
- Both of them are used for contraception.
- Dosing pattern of Slynd is similar to Yaz that includes administration of Drospirenone containing tablets once daily for 24 days followed by administration of placebo tablets for 4 days.
- Yaz prescribing information: Link
- Slynd Prescribing information: Link
#US granted patents on Fulvestrant by Fresenius
- US 10188663; US 9833459; US 9271990
Tentative 505(b)2 APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
23 May 2019 |
Pemetrexed disodium injections |
Biocon |
N/A |
N/A |
505(b)2 IN PIPELINE
Ethinyl Estradiol/Levonorgestrol Transdermal patch (Agile therapeutics): Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Ethinyl Estradiol/Levonorgestrol Transdermal patch (Twirla)
- Agile Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for Twirla® (AG 200-15). It’s a hormonal contraceptive patch.
- PDUFA goal date is 16 Nov. 2019.
- The patch is designed to apply once weekly for three weeks, followed by a week without patch.
- Full Press release: Link
AV001- injectable unapproved marketed product (Avadel Pharmaceuticals): Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for AV001
- Avadel Pharmaceuticals announced that the USFDA has accepted the New Drug Application (NDA) for the Company’s fourth Hospital Product, AV001.
- It’s a sterile injectable unapproved marketed drug for which Avadel has submitted 505(b)2 NDA application.
- As per company’s press release, subsequent to their NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001.
- PDUFA goal Date: September 15, 2019.
- Press Release: Link
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
17 May 2019 |
Rhodes Pharms |
Adderall XR (Shire) |
Seven |
|
|
20 May 2019 |
X-Gen Pharms |
Cosmegen (Recordati) |
One (Mylan) |
|
|
20 May 2019 |
Actavis |
Albenza (Impax) |
Four |
|
|
20 May 2019 |
Watson Labs |
Vesicare (Astellas) |
More Than 10 |
|
|
20 May 2019 |
Alembic Pharms |
|||
|
20 May 2019 |
Glenmark |
|||
|
20 May 2019 |
Qilu Pharm |
|||
|
20 May 2019 |
Amneal Pharms |
|||
|
20 May 2019 |
Breckenridge Pharm |
|||
|
20 May 2019 |
Cipla |
|||
|
20 May 2019 |
Alkem |
|||
|
20 May 2019 |
Jiangxi Boya |
|||
|
20 May 2019 |
Airis Pharma |
|||
|
20 May 2019 |
Msn Labs |
|||
|
20 May 2019 |
Sciegen P |
|||
|
20 May 2019 |
Amneal Pharms |
Depo-Medrol (Pharmacia And Upjohn) |
Five |
|
|
21 May 2019 |
Sun Pharm |
Ampyra (Acorda) |
Six |
|
|
22 May 2019 |
Zydus |
Nexium (Astrazeneca) |
Ten |
|
|
22 May 2019 |
Dr Reddys |
N/A |
One (Hospira) |
|
|
22 May 2019 |
Msn Labs |
Syprine (Aton) |
Four |
|
|
22 May 2019 |
Quagen |
N/A |
Five |
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
16 May 2019 |
Mylan |
|
|
16 May 2019 |
Prinston |
|
|
16 May 2019 |
Laurus Labs |
|
|
20 May 2019 |
Teva Pharms |
|
|
20 May 2019 |
Sun Pharm |
|
|
20 May 2019 |
Ajanta Pharma |
|
|
22 May 2019 |
Accord Hlthcare |
If you have any query/suggestion then please write us at pharmacaption@gmail.com
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